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Complex PCI

Your partner in complex PCI

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    Complex PCI cases are becoming more common, leading to an increased risk of adverse events.1

     

    Procedural guidance and vessel preparation tailored to the patient’s needs may help you overcome some of the challenges of complex PCI and achieve better outcomes.

     

    Philips provides a portfolio of specialty coronary diagnostic and therapy tools that enable safe and effective treatment for a wide variety of complex PCI cases. Explore the different morphologies seen in complex PCI cases and how these tools can help you succeed.

    In-stent restenosis (ISR)

     

    Real-world incidence rates of in-stent restenosis (ISR) account for 12% of PCI.2 Each patient requires a customized treatment strategy based on the extent and mechanism of their restenosis, requiring  flexibility in your toolkit and approach.3,4

    Rates of restenosis at follow up2

    In stent restenosis graph

    Clinical challenges

     

    • Target lesion revascularization rates remain an issue even today when using multiple overlapping stents.

    – 2nd stent 12-16% at 12 months and 33% at 3-5 years5  

    – 3rd stent 25% at 6 months5

     

    • Angiography alone cannot provide the information necessary to fully understand the mechanism and extent of ISR.3

    – Difficult to identify under-expansion or mal-apposition

    – Challenging to determine if it is geographical miss or under-sizing

    – Inability to discern between neointimal hyperplasia or neo-atherosclerosis

     

    • Traditional mechanical tools have limitations for treating ISR.

    – Mechanical tools, from angioplasty to rotational or orbital atherectomy, are largely ineffective in restenotic lesions.6

    – The unique soft, aqueous morphology of neointimal hyperplasia tissue presents a challenge to mechanical intervention.6

    Risk of restenosis

    Growing with each layer of stent5
    ISR clinical challenges

    Angiography cannot determine the mechanism of ISR

    ISR Angio

    Clinical challenges

     

    • Target lesion revascularization rates remain an issue even today when using multiple overlapping stents.

    – 2nd stent 12-16% at 12 months and 33% at 3-5 years5  

    – 3rd stent 25% at 6 months5

    Risk of restenosis

    Growing with each layer of stent5
    ISR clinical challenges
    • Angiography alone cannot provide the information necessary to fully understand the mechanism and extent of ISR.3

    – Difficult to identify under-expansion or mal-apposition

    – Challenging to determine if it is geographical miss or under-sizing

    – Inability to discern between neointimal hyperplasia or neo-atherosclerosis

     

    • Traditional mechanical tools have limitations for treating ISR.

    – Mechanical tools, from angioplasty to rotational or orbital atherectomy, are largely ineffective in restenotic lesions.6

    – The unique soft, aqueous morphology of neointimal hyperplasia tissue presents a challenge to mechanical intervention.6

    Angiography cannot determine the mechanism of ISR

    ISR Angio

    Philips is here to help you succeed in ISR cases

    Philips IVUS and SyncVision advanced imaging solution:

    • Help determine the mechanism of stent restenosis or stent thrombosis.
    • Allow optimization of treatment strategy and device utilization.
    • Help confirm pre and post therapy results.

     

    ELCA laser atherectomy catheter:

    • Modifies plaque, even behind struts, to facilitate stent expansion
    • Ablates lesion material.
    • Maximizes lumen for additional stent expansion and placement.

     

    AngioSculpt PTCA scoring balloon catheter:

    • Resists slipping within the vessel.
    • Provides improved luminal gain.8
    • Increases focal pressure to reset stents, minimizing the need for future additional stents.

     

    AngioSculptX Drug-Coated PTCA scoring balloon catheter:

    • Only device you need for both plaque scoring and drug delivery in challenging coronary cases such as ISR.
    • Built on Trusted AngioSculpt performance, designed for enhanced drug delivery: improving acute and long term outcomes while leaving nothing behind.
    • PATENT-C13,14 trial results demonstrate a significant improvement in late lumen loss (LLL) target lesion revascularization (TLR) and major adverse cardiac events (MACE) at 6-months and 24-months in the treatment of in-stent restenosis (ISR) Vs. bare AngioSculpt.
    Educational resources
    Prepare to succeed in ISR
    ISR case review – Allen Jeremias, MD, MSc
    ELCA case review – Anjan Gupta, MD and Romas Kirvaitis, MD
    2018 ESC/EACTS Guidelines on myocardial revascularization7
    Restenosis
    Class
    Level
    IVUS and/or OCT should be considered to detect stent-related mechanical problem leading to restenosis.
    IIa
    C
    Comparative luminal gain8
    ISR more luminal
    2018 ESC/EACTS Guidelines on myocardial revascularization7
    Restenosis
    DES are recommended for the treatment of in-stent restenosis of BMS or DES.9,10,11,12
    I
    A
    Drug-coated ballons are recommended for the treatment of in-stent restenosis of BMS or DES.9,10,11,12
    I
    A

    Philips IVUS and CoreVision advanced imaging solution:

    • Help determine the mechanism of stent restenosis or stent thrombosis.
    • Allow optimization of treatment strategy and device utilization.
    • Help confirm pre and post therapy results.
    2018 ESC/EACTS Guidelines on myocardial revascularization7
    Restenosis
    Class
    Level
    IVUS and/or OCT should be considered to detect stent-related mechanical problem leading to restenosis.
    IIa
    C

    ELCA laser atherectomy catheter:

    • Modifies plaque, even behind struts, to facilitate stent expansion
    • Ablates lesion material.
    • Maximizes lumen for additional stent expansion and placement.

     

    AngioSculpt PTCA scoring balloon catheter:

    • Resists slipping within the vessel.
    • Provides improved luminal gain.8
    • Increases focal pressure to reset stents, minimizing the need for future additional stents.
    Comparative luminal gain8
    ISR more luminal
    2018 ESC/EACTS Guidelines on myocardial revascularization7
    Restenosis
    DES are recommended for the treatment of in-stent restenosis of BMS or DES.9,10,11,12
    I
    A
    Drug-coated ballons are recommended for the treatment of in-stent restenosis of BMS or DES.9,10,11,12
    I
    A
    Educational resources
    Prepare to succeed in ISR
    ISR case review – Allen Jeremias, MD, MSc
    ELCA case review – Anjan Gupta, MD and Romas Kirvaitis, MD
    PATENT-C13,14 Trial results
    6-month in-segment LLL1
    6-month in-segment LLL
    24-month MACE (ITT analysis)2
    ISR more luminal

    Ostial and bifurcation lesions

     

    Ostial and bifurcation lesions represent nearly 40% of complex PCI’s.15

    Bifurcation lesions
    Philips image on file

    Clinical challenges

     

    • Ostial and bifurcation lesions are associated with higher rates of adverse cardiac events.16,17
    • Angiographic details of ostial and bifurcation lesions are often obscured due to angulation and overlap.
    • Identifying the proper treatment strategy is difficult with traditional angiography.
    • Risk of plaque or carina shift could cut off blood supply

    Philips is here to help you succeed in ostial and bifurcation cases

    89% reduction in all-cause mortality at 4 years18
    OB graph

    Philips IVUS and SyncVision advanced imaging solution:

    • Study data reported IVUS guidance was associated with an 89% reduction in all-cause mortality in bifurcation lesions and 50% reduction in the compsite of cardiovascular death, MI, or TLR in ostial lesions.16
    • Assist in identifying the true ostium, plaque distribution, vessel sizez and lesion length.
    • Aid in therapy delivery by avoiding geographic miss or extending stent struts into the ostium.
    • Co-registration allows you to more easily coorelate plaque and treatment locations to the angiogram.
    Ostial monitor

    Images provided courtesy of Allen Jeremias, MD, MSc

    Image illustrates CoreVision's Device Detection software which enables easy visualization of therapy delivery.

    AngioSculpt PTCA scoring balloon catheter:

    • Helps you apply maximum dilation force with less risk of dissection compared to other PTCA balloons.19
    • Avoids slippage during dilation by locking in place with its unique rectangular nitinol scoring elements.
    • Associated with excellent and safe procedural results, a low rate of crossover to side-branch stenting, and favorable outcomes for the treatment of true bifurcation lesions.20

    ELCA laser atherectomy catheter:

    • The only coronary atherectomy device with an ostial lesion indication.
    • Vaporizes multiple plaque morphologies at the ostium to avoid plaque shift.
    • Delivers over any wire and can be used with multiple wires in place.
    Educational resources
    ELCA case review of CFX subtotal occlusion – Antonis Pratsos, MD
    ELCA case review – Jack Casas, MD, FACC

    Chronic total occulsions (CTOs)


    Incidence increases with age, yet older patients are less likely to have PCI attempted.21 Furthermore, 18% of PCIs have a CTO, but less than 5% are being treated.22
    CTOs
    CTO of the RCA - image provided by Craig Thompson, MD

    Clinical challenges

     

    • CTOs are difficult to wire and re-canalize, resulting in lengthy procedures and potentially higher radiation exposure and contrast use.
    • CTOs are often associated with lower procedural success rates, increased restenosis and re-occlusion compared with non-CTO procedures.23,24
    • Hard proximal caps often prevent therapy from being delivered.

    Philips is here to help you succeed in CTO cases 

    Philips IVUS and SyncVision advanced imaging solution:

    • Help optimize vessel sizing for treatment strategy and to confirm your result after successful re-canalization.
    • Provide enhanced and stabilized angiographic views to optimize therapy delivery.
    • Study data reported when IVUS was used to help guide treatment there was significantly lower 12 month MACE and cardiac death rate vs angiography alone.25
    IVUS-guided vs. angiography-guided outcomes25
    CTO Angio vs IVUS graph

    AngioSculpt PTCA scoring balloon catheter

    • Provides the power necessary to maximize lumen diameter once a wire crosses.
    • Delivers 15-25x’s the focal force of a traditional balloon.26

    ELCA laser atherectomy catheter:

    • The only coronary atherectomy device with a CTO indication.
    • Enables crossing 94% of lesions which previously failed balloon angioplasty.27
    • Modifies the plaque, creates a channel, and enables the delivery of other therapeutic devices.
    • Delivers over any wire already across a CTO, unlike other atherectomy devices.
    Educational resources
    ELCA case review CTO in LAD – Rakesh Bhan, MD
    ELCA case review radial CTO of LAD
    ELCA case review LAD – Gaurav Aggarwala, MD
    ELCA case review Circumflex – Antonis Pratsos, MD
    ELCA Success and safety rates
    Study
    Lesion type

    Technical 

    success
    Procedural success
    MACE Rates*
    Bilodeau
    Calcified and complex coronary lesions20
    92.0%
    93.0%
    8.0%
    Calcified, uncrossable, resistant coronary lesions20
    95.5%
    95.5%
    8.0%
    Pratsos
    Crossable coronary lesions6
    98.1%
    99.0%
    0.0%
    Educational resources
    ELCA case review CTO in LAD – Rakesh Bhan, MD
    ELCA case review radial CTO of LAD
    ELCA case review LAD – Gaurav Aggarwala, MD
    ELCA case review Circumflex – Antonis Pratsos, MD

    Calcified lesions


    An increasing number of patients with calcified coronary artery lesions are being referred for PCI.  A recent pooled analysis reported moderate to severe target lesion calcification in 32% of patients.28
    Digital grayscale EEP plaque with calcium
    Philips image on file

    Clinical challenges


    • Angiographic measures of procedural success, such as acute gain and diameter stenosis, are often worse in calcified lesions.29,30,31
    • Stent under-expansion, asymmetric expansion, and mal-apposition are frequently observed in heavily calcified lesions.32,33,34
    • Noncompliant calcified plaques often require high-pressure balloon dilation, increasing the risk for adverse events such as coronary dissection and thrombosis.35,29,20
    Calcified lesion chromaflo
    Philips image on file

    Philips is here to help you succeed in calcified lesion cases

     

    Philips IVUS and SyncVision advanced imaging solution:

    • Help detect coronary artery calcification better than coronary angiography, which has a low-moderate sensitivity.36,37,38
    • Help quantify and distinguish the calcium burden, which may impact your treatment strategy.

    AngioSculpt PTCA scoring balloon catheter:

    • Delivers 15-25x’s the focal force of a traditional balloon with its nitinol scoring element.19
    • Improves vessel compliance by scoring plaque, enabling greater lesion expansion and reducing recoil while preventing uncontrolled dissections.

     

    ELCA laser atherectomy catheter:

    • The only coronary atherectomy device with a moderate calcium indication.
    • Demonstrates procedural effectiveness in crossing and modifying calcified lesions previously resistant to traditional balloon techniques.25
    • Adjustable high frequency settings to modify plaque and can be facilitated with any wire.
    Educational resources
    ELCA case study: Long, calcified CTO of cicumflex – Antonis Pratsos, MD
    Bilodeau study sheet
    LEONARDO clinical abstract
    Recanalization of LAD - Robert Lee Jobe, MD

    Diffuse disease


    Approximately 20% of the coronary lesions treated today are greater than 20mm in length.39,40
    Diffuse disease
    Image courtesy of Alphonse Ambrosia, DO

    Clinical challenges

     

    • Diffuse or long lesions are associated with decreased procedural success and are associated with higher rates of restenosis.41

    – Stent length is an independent predictor of in-stent restenosis and thrombosis42 

    – Stenting long segments with multiple and or overlapping stents may lead to injury to the vessel wall integrity43

     

    • Angiography alone may not be able to identify the critical lesion.

    – Diffuse CAD may be underestimated by evaluation with coronary angiography44

    – Determining reference vessel sizing can be challenging when the vessel is diffusely diseased45

    Philips is here to help you succeed in diffuse disease cases

     

    Philips physiology tools and SyncVision advanced imaging solution:

    • Map iFR physiological drops to understand whether there is diffuse or focal disease.
    • Make length measurements without a pullback device, plan your procedure and see the physiologic impact of a virtual stent.

     

    Philips IVUS and SyncVision advanced imaging solution:

    • Guide stenting of the most severely diseased areas, sparing the need for implantation of long stents and can be associated with better outcomes.46
    • Study data (IVUS-XPL) reported IVUS was associated with a 52% reduction in MACE at 1 year with Xience Prime stents ≥28 mm.47

     

    AngioSculpt PTCA scoring balloon catheter: 

    • Provides improved luminal gain throughout segment, which helps facilitate stent delivery.8

     

    ELCA laser atherectomy catheter:

    • Creates a channel to facilitate definitive therapy delivery.
    • Prepares long segment to optimize stent and wall apposition (indicated for lesions >20mm).
    Educational resources
    ELCA case study RCA – Antonis Pratsos, MD
    Diffuse disease iFR multiple length
    Philips image on file
    52% reduction graphic

    Comparative luminal gain8

    (P=0.004)

    ISR more Luminal

    Philips is here to help you prepare to succeed in diffuse disease cases

     

    Philips physiology tools and CoreVision advanced imaging solution:

    • Map iFR physiological drops to understand whether there is diffuse or focal disease.
    • Make length measurements without a pullback device, plan your procedure and see the physiologic impact of a virtual stent.
    Diffuse disease iFR multiple length
    Philips image on file

    Philips IVUS and CoreVision advanced imaging solution:

    • Guide stenting of the most severely diseased areas, sparing the need for implantation of long stents and can be associated with better outcomes.39
    • Study data (IVUS-XPL) reported IVUS was associated with a 52% reduction in MACE at 1 year with Xience Prime stents ≥28 mm.40
    52% reduction graphic
    AngioSculpt PTCA scoring balloon catheter: 
    • Treats small distal vessels not amenable to stenting. 
    • Provides improved luminal gain throughout segment, which helps facilitate stent delivery.8

    Comparative luminal gain8

    (P=0.004)

    ISR more Luminal

    ELCA laser atherectomy catheter:

    • Creates a channel to facilitate definitive therapy delivery.
    • Prepares long segment to optimize stent and wall apposition (indicated for lesions >20mm).
    Educational resources
    ELCA case study RCA – Antonis Pratsos, MD

    Left main disease


    Significant left main CAD (greater than 50%) is found in 4-6% of all patients who undergo coronary angiography.48
    LMD image
    Image courtesy of Jaikirshan Khatri, MD, FACC, FSCAI

    Clinical challenges

     

    • Left main angiography is highly uncertain49 and can underestimate lesion severity.50
    • Potential dire consequences of stent thrombosis or restenosis.51
    • Left main disease is associated with multi-vessel CAD about 70% of the time.52,53

    Philips is here to help you succeed in left main lesion disease

    Philips IVUS and SyncVision advanced imaging solution:

    • Assist in identifying the plaque distribution, vessel size and help avoid geographic miss of therapy delivery with IVUS Co-registration. 
    • Are backed by 2018 ESC/EACTS Class IIa usage guidance for left main.47
    • Provide better patient outcomes as an IVUS-guided strategy is associated with 70% reduction in all-cause mortality out to 3 years.48

     

    AngioSculpt PTCA scoring balloon catheter: 

    • Has a large working range (2 ATM up to 20 ATM) allowing you to quickly tailor you strategy to the vessel size. 
    • Data shows that lesion preparation with a circumferential scoring element led to a numerically larger lumen and low TLR rates in left main interventions.58
    Educational resources
    ELCA case review – Jaikirshan (Jai) Khatri, MD, FACC, FSCAI
    Recommendations
    Class
    Level
    IVUS should be considered to optimize treatment of unprotected left main lesions.54
    IIa
    B
    IVUS should be considered to assess the severity of unprotected lef main lesions.54-56
    IIa
    B
    70% reduction in all-cause mortality out to 3 yrs57
    LMD graph

     

    Philips IVUS and CoreVision advanced imaging solution:

    • Assist in identifying the plaque distribution, vessel size and help avoid geographic miss of therapy delivery with IVUS Co-registration. 
    • Are backed by ACC/AHA Class IIa usage guidance for left main.47
    • Provide better patient outcomes as an IVUS-guided strategy is associated with 70% reduction in all-cause mortality out to 3 years.48
    70% reduction in all-cause mortality out to 3 yrs48
    LMD graph

    AngioSculpt PTCA scoring balloon catheter: 

    • Has a large working range (2 ATM up to 20 ATM) allowing you to quickly tailor you strategy to the vessel size. 
    • Data shows that lesion preparation with a circumferential scoring element led to a numerically larger lumen and low TLR rates in left main interventions.49
    Educational resources
    ELCA case review – Jaikirshan (Jai) Khatri, MD, FACC, FSCAI

    Saphenous vein graft and thrombus lesions

     

    Saphenous vein graft (SVG) occlusion during the first year is high at 15%, and 10-year patency is only 60%.59,60,61,62

    Rotational IVUS Refinity
    Philips image on file

    Clinical challenges

     

    • Tough fibrotic lesions are at the anastomosis site.
    • There is a risk of distal emboli.
    • Safe delivery of embolic protection.
    • Higher MACE and ISR rates are associated with these cases.63,64,65

    Philips is here to help you succeed in SVG and thrombus cases

    Philips IVUS and SyncVision advanced imaging solution:

    • Assist in identifying the extent of thrombus or plaque distribution, vessel sizes and lesion length. 
    • Allow you to more easily correlate plaque and treatment locations to the angiogram with the goal of reduced contrast load and radiation exposure with IVUS Co-registration.

     

    AngioSculpt PTCA scoring balloon catheter: 

    • Provides maximal lumen gain under low pressure (nominal 8 ATM).

     

    ELCA laser atherectomy catheter:

    • Is the only coronary atherectomy device with an SVG indication.
    • Vaporizes the plaque and often used to assist in delivering embolic protection. 
    Educational resources
    ELCA SVG case review – Antonis Pratsos, MD
    ELCA SVG case review
    Laser in thrombus video
    Play
    Philips video on file -  ELCA laser catheter
    Educational resources
    ELCA SVG case review – Antonis Pratsos, MD
    ELCA SVG case review

    Educational opportunities and trainings

    PEAcademy logos PEA
    PEAcademy logos KTL
    PEAcademy logos CE
    PEAcademy logos PK

    Educating leaders in intravascular imaging and therapy excellence

    Philips ELIITE Academy is focused on delivering high value and real-time strategic educational programs that meet the evolving needs of our customers.


    To initiate your clinical pathway or register for one our cardiovascular US medical educational programs, please contact your local Philips representative.


    For more information on the available courses, please download our Medical Education brochure or visit www.philipseliiteacademy.com.

    Philips is your partner in complex PCI with specialty coronary diagnostic and therapy devices

    ELCA
    ELCA coronary laser atherectomy catheter
    View product
    Angiosculpt
    AngioSculpt PTCA scoring balloon catheter
    View product
    Corevisio
    SyncVision advanced imaging solution with Co-registration
    View product
    EEP
    Eagle Eye Platinum digital IVUS catheter
    View product
    EEP ST
    Eagle Eye Platinum ST digital IVUS catheter
    View product
    Refinity ST
    Refinity ST rotational IVUS catheter
    View product
    IVUS imaging
    IVUS imaging
    View product
    IVUS imaging
    Verrata Plus pressure guide wire
    View product
    Anio Sculpt X
    AngioSculptX Drug-Coated PTCA scoring balloon catheter
    View product
    iFR co-registration
    iFR Co-registration technology
    View product

    Resources

    Bookmark icon
    Educational resources
    Inside information for IVUS
    Eagle Eye Platinum IVUS pocket guide
    Hand app icon
    Downloadable iOS app
    Coronary IVUS app
    References and safety information
    1. Witzenbichler B et al. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents: The ADAPT-DES Study. Circulation 2014 Jan: 129,4;463-470.
    2. Cassese S, Byrne RA, Tada T, et al. Incidence and predictors of restenosis after coronary stenting in 10,004 patients with surveillance angiography. Heart 2014; 100:153–9.
    3. Dangas et a. In-Stent Restenosis in the Drug-Eluting Stent Era. J Am Coll Cardiol 2010; 56:1897–907.
    4. Bhatt D. Treatment of In-Stent Restenosis, Excerpt from Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease. Philadelphia: Elsevier 2016:209-222.
    5. Ota H. Novel Approaches for Cardiovascular Drug-Eluting Devices Cardiovasc Revasc Med. 2015; 16:84-89; Maluenda G. Intracoronary brachytherapy for Recurrent Drug-Eluting Stent Failure CardiovascInterv. 2012;5:12-19; Kubo S. Differential relative efficacy between drug-eluting stents in patients with bare metal and drug-eluting stent restenosis Euro Intervention. 2013;9:788-796; Latib A. Long-term outcomes after the percutaneous treatment of drug-eluting stent restenosisJACC Cardiovasc Interv. 2011;4:155-164.
    6. Pratsos, A. (2009). Atherectomy and the role of excimer laser in treating CAD. Cardiac Interventions Today, January/February, 27-34.
    7. Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Jüni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group,'2018 ESC/EACTS Guidelines on myocardial revascularization., Eur J Cardiothorac Surg. 2018 Aug 27. doi: 10.1093/ejcts/ezy289
    8. Costa JR, Mintz GS, Carlier SG, et al. Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol. 2007;100:812-817.
    9. Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Seidelberger B, Iniguez A, Gomez-Recio M, Masotti M, Velazquez MT, Sanchis J, Garcia-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, Lopez-Minguez JR, Moreu J, Marti V, Moreno R, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: The RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol 2014;63:1378–1386.
    10. Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Benedicto A, Masotti M, Zueco J, Iniguez A, Velazquez M, Moreno R, Mainar V, Dominguez A, Pomar F, Melgares R, Rivero F, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C, RIBS IV Investigators. A prospective randomized trial of drug-eluting balloons versus everolimus-eluting stents in patients with in-stent restenosis of drug-eluting stents: The RIBS IV randomized clinical trial. J Am Coll Cardiol 2015; 66:23–33.
    11. Siontis GC, Stefanini GG, Mavridis D, Siontis KC, Alfonso F, Perez-Vizcayno MJ, Byrne RA, Kastrati A, Meier B, Salanti G, Juni P, Windecker S. Percutaneous coronary interventional strategies for treatment of in-stent restenosis: A network meta-analysis. Lancet 2015;386:655–664.
    12. Giacoppo D, Gargiulo G, Aruta P, Capranzano P, Tamburino C, Capodanno D. Treatment strategies for coronary in-stent restenosis: Systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients. BMJ 2015; 351:h5392.
    13. Scheller B, Fontaine T, Mangner N, et al. A Novel Drug-Coated Scoring Balloon for the Treatment of Coronary In-Stent Restenosis: Results from the Nulti-Center Randomized Controlled PATENT-C First in Human Trial. Cath and Cardiovasc Interv. 2016; 88:51-59.
    14. Scheller et al. “A Novel Drug-Coated Scoring Balloon for the Treatment of Coronary In-Stent Restenosis Two-Year Results from the PATENT-C First-in-Human Trial,” TCT 2015
    15. Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9.
    16. Patel et al. Impact of intravascular ultrasound on the long-term clinical outcomes in the treatment of coronary ostial lesions. Catheter Cardiovasc Interv 2013 June 1. In press doi: 10.1002/ccd.25034.)
    17. Iakovou I, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug eluting stents. JAMA 2005;293:2126:2130.
    18. Kim, S, Kim Y, et al, Long-Term Outcomes of Intravascular Ultrasound-Guided Stenting in Coronary Bifurcation Lesions, Am J Cardiol 2010;106:612– 618.
    19. Mooney M, Teirstein P, Moses J, et al. Final results from the U.S. multi-center trial of the AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary artery lesions. Am J Cardiol. 2006;98 (suppl 8):121M.
    20. Weisz G, Metzger DC, Liberman HA, O’Shaughnessy CD, Douglas JS, Turco MA, Mehran R, Gershony G, Leon MB, Moses JW. A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch: Final Results of the AGILITY Trial. Catheterization and Cardiovascular Interventions 2013;82(3):352-359.
    21. Stone, G., et. al. (2005). Percutaneous recanalization of chronically occluded coronary arteries: A consensus document: Part 1. Circulation, 112, 2364- 2372.
    22. National Cardiac Data Registry -2016
    23. Rasmussen, K., et al. (2010). Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care(SORT OUT III): A randomized controlled superiority trial. The Lancet, 375(9720), 1090-1099.
    24. Byrne, R.A., Kastrati, A., et. al. (2009). Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the intracoronary stenting and angiographic results: Test efficacy of 3 limus-eluting stents (ISAR-TEST-4) trial. Eur Heart J, 30, 2441-2449.
    25. Kim BK, Shin DH, Hong MK, et al. Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation: randomized study. Circ Cardiovasc Interv 2015;8:e002592.
    26. AngioSculpt Test plan ST-1197 (2008) on file at AngioScore, Inc.
    27. Luc Bilodeau, MD, et al. Novel Use of a High-Energy Excimer Laser Catheter for Calcified and Complex Coronary Artery Lesions. Catheterization and Cardiovascular Interventions (62:155-161, 2004).
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