Vessel Injury in Relation With Strut Thickness Assessed by OCT

NCT03026465 | Completed Phase 4 DMC

• 1 other identifier: VISTA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• OCT-based intimal injury score

  OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES

  Up to 1 day (evaluated after stent implantation)

Secondary Outcomes (5)

• Tissue prolapse area

  Up to 1 day (evaluated after stent implantation)

• Incidence of stent malapposition

  Up to 1 day (evaluated after stent implantation)

• Incidence of stent underexpansion

  Up to 1 day (evaluated after stent implantation)

• Stent symmetry after implantation

  Up to 1 day (evaluated after stent implantation)

• Baseline plaque type

  Up to 1 day (evaluated after stent implantation)

Study Arms (2)

Coroflex ISAR stent

EXPERIMENTAL

PCI with a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR stent) with very thin struts (50 µm). During the PCI, an OCT assessment (baseline and post-implantation) will be performed.

Device: Polymer-free stent

Biomatrix stent

ACTIVE COMPARATOR

PCI with a biodegradable-polymer biolimus-eluting stent (Biomatrix stent) with 120 µm struts. During the PCI, an OCT assessment (baseline and post-implantation) will be performed.

Device: Biodegradable-polymer stent

Interventions

Polymer-free stent DEVICE

PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)

Also known as: Coroflex ISAR

Coroflex ISAR stent

Biodegradable-polymer stent DEVICE

PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)

Also known as: Biomatrix

Biomatrix stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years
• Ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of \>50% de novo stenosis located in native coronary vessels

You may not qualify if:

• Target lesion located in the left main stem
• STEMI
• Restenosis
• Cardiogenic shock
• Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance
• Known allergy to the study medications (probucol, sirolimus, zotarolimus)
• Pregnancy (present, suspected, or planned)

Sponsors & Collaborators

• Fundacion Investigacion Interhospitalaria Cardiovascular: lead
• B.Braun Surgical SA: collaborator

Study Sites (3)

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario de La Princesa

Madrid, Spain

Location

Related Publications (25)

• Sullivan TM, Ainsworth SD, Langan EM, Taylor S, Snyder B, Cull D, Youkey J, Laberge M. Effect of endovascular stent strut geometry on vascular injury, myointimal hyperplasia, and restenosis. J Vasc Surg. 2002 Jul;36(1):143-9. doi: 10.1067/mva.2002.122878.

  PMID: 12096272 BACKGROUND

• Hara H, Nakamura M, Palmaz JC, Schwartz RS. Role of stent design and coatings on restenosis and thrombosis. Adv Drug Deliv Rev. 2006 Jun 3;58(3):377-86. doi: 10.1016/j.addr.2006.01.022. Epub 2006 Mar 6.

  PMID: 16650911 BACKGROUND

• Farb A, Weber DK, Kolodgie FD, Burke AP, Virmani R. Morphological predictors of restenosis after coronary stenting in humans. Circulation. 2002 Jun 25;105(25):2974-80. doi: 10.1161/01.cir.0000019071.72887.bd.

  PMID: 12081990 BACKGROUND

• Rogers C, Edelman ER. Endovascular stent design dictates experimental restenosis and thrombosis. Circulation. 1995 Jun 15;91(12):2995-3001. doi: 10.1161/01.cir.91.12.2995.

  PMID: 7796511 BACKGROUND

• Scott NA. Restenosis following implantation of bare metal coronary stents: pathophysiology and pathways involved in the vascular response to injury. Adv Drug Deliv Rev. 2006 Jun 3;58(3):358-76. doi: 10.1016/j.addr.2006.01.015. Epub 2006 Mar 6.

  PMID: 16733073 BACKGROUND

• Foin N, Lee RD, Torii R, Guitierrez-Chico JL, Mattesini A, Nijjer S, Sen S, Petraco R, Davies JE, Di Mario C, Joner M, Virmani R, Wong P. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol. 2014 Dec 20;177(3):800-8. doi: 10.1016/j.ijcard.2014.09.143. Epub 2014 Oct 7.

  PMID: 25449502 BACKGROUND

• Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, Coleman L, Wong GK, Edelman ER. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011 Apr 5;123(13):1400-9. doi: 10.1161/CIRCULATIONAHA.110.003210. Epub 2011 Mar 21.

  PMID: 21422389 BACKGROUND

• Foin N, Gutierrez-Chico JL, Nakatani S, Torii R, Bourantas CV, Sen S, Nijjer S, Petraco R, Kousera C, Ghione M, Onuma Y, Garcia-Garcia HM, Francis DP, Wong P, Di Mario C, Davies JE, Serruys PW. Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition. Circ Cardiovasc Interv. 2014 Apr;7(2):180-9. doi: 10.1161/CIRCINTERVENTIONS.113.000931. Epub 2014 Mar 18.

  PMID: 24642998 BACKGROUND

• Bourantas CV, Papafaklis MI, Kotsia A, Farooq V, Muramatsu T, Gomez-Lara J, Zhang YJ, Iqbal J, Kalatzis FG, Naka KK, Fotiadis DI, Dorange C, Wang J, Rapoza R, Garcia-Garcia HM, Onuma Y, Michalis LK, Serruys PW. Effect of the endothelial shear stress patterns on neointimal proliferation following drug-eluting bioresorbable vascular scaffold implantation: an optical coherence tomography study. JACC Cardiovasc Interv. 2014 Mar;7(3):315-24. doi: 10.1016/j.jcin.2013.05.034. Epub 2014 Feb 13.

  PMID: 24529931 BACKGROUND

• Kastrati A, Mehilli J, Dirschinger J, Dotzer F, Schuhlen H, Neumann FJ, Fleckenstein M, Pfafferott C, Seyfarth M, Schomig A. [Intracoronary Stenting and Angiographic Results Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) Trial]. Vestn Rentgenol Radiol. 2012 Mar-Apr;(2):52-60. Russian.

  PMID: 22730760 BACKGROUND

• Pache J, Kastrati A, Mehilli J, Schuhlen H, Dotzer F, Hausleiter J, Fleckenstein M, Neumann FJ, Sattelberger U, Schmitt C, Muller M, Dirschinger J, Schomig A. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol. 2003 Apr 16;41(8):1283-8. doi: 10.1016/s0735-1097(03)00119-0.

  PMID: 12706922 BACKGROUND

• Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.

  PMID: 16814667 BACKGROUND

• Koppara T, Joner M, Bayer G, Steigerwald K, Diener T, Wittchow E. Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation. Thromb Haemost. 2012 Jun;107(6):1161-71. doi: 10.1160/TH12-01-0043. Epub 2012 Apr 26.

  PMID: 22535188 BACKGROUND

• Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

  PMID: 17438147 BACKGROUND

• Joner M, Nakazawa G, Finn AV, Quee SC, Coleman L, Acampado E, Wilson PS, Skorija K, Cheng Q, Xu X, Gold HK, Kolodgie FD, Virmani R. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol. 2008 Jul 29;52(5):333-42. doi: 10.1016/j.jacc.2008.04.030.

  PMID: 18652940 BACKGROUND

• Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007 Jul;27(7):1500-10. doi: 10.1161/ATVBAHA.107.144220. Epub 2007 May 17.

  PMID: 17510464 BACKGROUND

• Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, Juni P, Schomig A, Windecker S, Kastrati A. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. Eur Heart J. 2012 May;33(10):1214-22. doi: 10.1093/eurheartj/ehs086. Epub 2012 Mar 24.

  PMID: 22447805 BACKGROUND

• Smits PC, Hofma S, Togni M, Vazquez N, Valdes M, Voudris V, Slagboom T, Goy JJ, Vuillomenet A, Serra A, Nouche RT, den Heijer P, van der Ent M. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013 Feb 23;381(9867):651-60. doi: 10.1016/S0140-6736(12)61852-2. Epub 2013 Jan 30.

  PMID: 23374650 BACKGROUND

• Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53.

  PMID: 26196753 BACKGROUND

• Otsuka F, Cheng Q, Yahagi K, Acampado E, Sheehy A, Yazdani SK, Sakakura K, Euller K, Perkins LEL, Kolodgie FD, Virmani R, Joner M. Acute Thrombogenicity of a Durable Polymer Everolimus-Eluting Stent Relative to Contemporary Drug-Eluting Stents With Biodegradable Polymer Coatings Assessed Ex Vivo in a Swine Shunt Model. JACC Cardiovasc Interv. 2015 Aug 17;8(9):1248-1260. doi: 10.1016/j.jcin.2015.03.029.

  PMID: 26292590 BACKGROUND

• Otsuka F, Yahagi K, Ladich E, Kutys R, Alexander R, Fowler D, Virmani R, Joner M. Hypersensitivity reaction in the US Food and Drug Administration-approved second-generation drug-eluting stents: histopathological assessment with ex vivo optical coherence tomography. Circulation. 2015 Jan 20;131(3):322-4. doi: 10.1161/CIRCULATIONAHA.114.012658. No abstract available.

  PMID: 25601953 BACKGROUND

• Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, Ibrahim T, Fusaro M, Ott I, Schomig A, Laugwitz KL, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial. Circulation. 2011 Aug 2;124(5):624-32. doi: 10.1161/CIRCULATIONAHA.111.026732. Epub 2011 Jul 18.

  PMID: 21768546 BACKGROUND

• Alfonso F, Sandoval J, Perez-Vizcayno MJ, Cardenas A, Gonzalo N, Jimenez-Quevedo P, Ibanez B, Nunez-Gil I, Rivero F, Escaned J, Fernandez-Ortiz A, Macaya C. Mechanisms of balloon angioplasty and repeat stenting in patients with drug-eluting in-stent restenosis. Int J Cardiol. 2015 Jan 15;178:213-20. doi: 10.1016/j.ijcard.2014.10.139. Epub 2014 Oct 23.

  PMID: 25464257 BACKGROUND

• Gonzalo N, Serruys PW, Okamura T, Shen ZJ, Onuma Y, Garcia-Garcia HM, Sarno G, Schultz C, van Geuns RJ, Ligthart J, Regar E. Optical coherence tomography assessment of the acute effects of stent implantation on the vessel wall: a systematic quantitative approach. Heart. 2009 Dec;95(23):1913-9. doi: 10.1136/hrt.2009.172072. Epub 2009 Aug 10.

  PMID: 19671534 BACKGROUND

• Vilchez-Tschischke JP, Salazar C, Gil-Romero J, Mori R, Nunez-Gil I, Quiros A, Nombela L, Del Trigo M, Jimenez-Quevedo P, Salinas P, Escaned J, Macaya C, Gonzalo N. Stent strut thickness and acute vessel injury during percutaneous coronary interventions: an optical coherence tomography randomized clinical trial. Coron Artery Dis. 2021 Aug 1;32(5):382-390. doi: 10.1097/MCA.0000000000000943.

  PMID: 32826450 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Nieves Gonzalo, MD, PhD

  Hospital Clinico San Carlos de Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: January 20, 2017
• Study Start: February 16, 2017
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)