Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent

NCT00617084 | Completed Phase 4 Results DMC

• 1 other identifier: Version 1.2 - IP090
• Study Type: interventional
• Target: 2,292
• Locations: 1 country
• Sites: 1

Brief Summary

The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study. Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.

Conditions

Coronary Artery Disease

Keywords

Drug Eluting Stents; Interventional Cardiology

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure

  Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.

  12 months

Secondary Outcomes (1)

• In-Stent Percent Diameter Stenosis

  13 Months

Study Arms (2)

1. Resolute

ACTIVE COMPARATOR

Medtronic Endeavor Resolute

Device: Medtronic Endeavor Resolute

2. XIENCE V

ACTIVE COMPARATOR

Abbott Xience V

Device: Abbott Xience V

Interventions

Medtronic Endeavor Resolute DEVICE

Medtronic Endeavor Resolute

Also known as: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System

1. Resolute

Abbott Xience V DEVICE

Abbott Xience V

Also known as: XIENCE V Everolimus Eluting Coronary Stent System

2. XIENCE V

Eligibility Criteria

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

You may qualify if:

• Minimal age 18 years
• Symptomatic coronary artery disease
• Patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
• Presence of one or more coronary artery stenosis \>50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
• Patient indication, lesion length and vessel diameter according to 'Instructions for Use' of study stents
• Patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing EC approved written informed consent.

You may not qualify if:

• Women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
• Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, Zotarolimus, Everolimus, or contrast material
• Participating in other trial before reaching primary endpoint
• Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.

Sponsors & Collaborators

• Medtronic Vascular: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (1)

Stiftung Inselspital, Department of Cardiology

Bern, CH-3010, Switzerland

Location

Related Publications (21)

• Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Raber L, Heg D, Juni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.

  PMID: 26823484 DERIVED

• Iqbal J, Serruys PW, Silber S, Kelbaek H, Richardt G, Morel MA, Negoita M, Buszman PE, Windecker S. Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002230. doi: 10.1161/CIRCINTERVENTIONS.114.002230.

  PMID: 26047993 DERIVED

• Taniwaki M, Windecker S, Zaugg S, Stefanini GG, Baumgartner S, Zanchin T, Wenaweser P, Meier B, Juni P, Raber L. The association between in-stent neoatherosclerosis and native coronary artery disease progression: a long-term angiographic and optical coherence tomography cohort study. Eur Heart J. 2015 Aug 21;36(32):2167-76. doi: 10.1093/eurheartj/ehv227. Epub 2015 Jun 3.

  PMID: 26040806 DERIVED

• Campos CM, Costa F, Garcia-Garcia HM, Bourantas C, Suwannasom P, Valgimigli M, Morel MA, Windecker S, Serruys PW. Anatomic characteristics and clinical implications of angiographic coronary thrombus: insights from a patient-level pooled analysis of SYNTAX, RESOLUTE, and LEADERS Trials. Circ Cardiovasc Interv. 2015 Apr;8(4):e002279. doi: 10.1161/CIRCINTERVENTIONS.114.002279.

  PMID: 25825008 DERIVED

• Taniwaki M, Radu MD, Garcia-Garcia HM, Heg D, Kelbaek H, Holmvang L, Moschovitis A, Noble S, Pedrazzini G, Saunamaki K, Dijkstra J, Landmesser U, Wenaweser P, Meier B, Stefanini GG, Roffi M, Luscher TF, Windecker S, Raber L. Long-term safety and feasibility of three-vessel multimodality intravascular imaging in patients with ST-elevation myocardial infarction: the IBIS-4 (integrated biomarker and imaging study) substudy. Int J Cardiovasc Imaging. 2015 Jun;31(5):915-26. doi: 10.1007/s10554-015-0631-0. Epub 2015 Feb 28.

  PMID: 25721728 DERIVED

• Taniwaki M, Stefanini GG, Silber S, Richardt G, Vranckx P, Serruys PW, Buszman PE, Kelbaek H, Windecker S; RESOLUTE All-Comers Investigators. 4-year clinical outcomes and predictors of repeat revascularization in patients treated with new-generation drug-eluting stents: a report from the RESOLUTE All-Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). J Am Coll Cardiol. 2014 Apr 29;63(16):1617-25. doi: 10.1016/j.jacc.2013.12.036. Epub 2014 Feb 13.

  PMID: 24530680 DERIVED

• Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.

  PMID: 24510638 DERIVED

• Richardt G, Leschke M, Abdel-Wahab M, Toelg R, El-Mawardy M, Serruys PW, Silber S, Windecker S, Belardi JA, Neumann FJ, Widimsky P; RESOLUTE All Comers; RESOLUTE International Investigators. Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. JACC Cardiovasc Interv. 2013 Sep;6(9):905-13. doi: 10.1016/j.jcin.2013.04.017. Epub 2013 Aug 14.

  PMID: 23954063 DERIVED

• Gutierrez-Chico JL, Raber L, Regar E, Okamura T, di Mario C, van Es GA, Windecker S, Serruys PW. Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: in vivo assessment with optical coherence tomography. Am Heart J. 2013 Jul;166(1):83-94. doi: 10.1016/j.ahj.2013.04.001. Epub 2013 May 3.

  PMID: 23816026 DERIVED

• Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20.

  PMID: 23523454 DERIVED

• Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6.

  PMID: 23468513 DERIVED

• Vranckx P, Farooq V, Garg S, Van Es GA, Silber S, Windecker S, Stone GW, Serruys PW. Different cardiac biomarkers to detect peri-procedural myocardial infarction in contemporary coronary stent trials: impact on outcome reporting. Heart. 2012 Oct;98(19):1424-30. doi: 10.1136/heartjnl-2012-302267. Epub 2012 Jul 21.

  PMID: 22821273 DERIVED

• Stefanini GG, Kalesan B, Pilgrim T, Raber L, Onuma Y, Silber S, Serruys PW, Meier B, Juni P, Windecker S. Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents. JACC Cardiovasc Interv. 2012 Mar;5(3):301-10. doi: 10.1016/j.jcin.2011.11.011.

  PMID: 22440496 DERIVED

• Gutierrez-Chico JL, Wykrzykowska J, Nuesch E, van Geuns RJ, Koch KT, Koolen JJ, di Mario C, Windecker S, van Es GA, Gobbens P, Juni P, Regar E, Serruys PW. Vascular tissue reaction to acute malapposition in human coronary arteries: sequential assessment with optical coherence tomography. Circ Cardiovasc Interv. 2012 Feb 1;5(1):20-9, S1-8. doi: 10.1161/CIRCINTERVENTIONS.111.965301. Epub 2012 Feb 7.

  PMID: 22319063 DERIVED

• Gomez-Lara J, Heo JH, Brugaletta S, Garg S, Garcia-Garcia HM, van Geuns RJ, Silber S, Windecker S, Serruys PW. Risk of target lesion failure in relationship to vessel angiographic geometry and stent conformability using the second generation of drug-eluting stents. Am Heart J. 2011 Dec;162(6):1069-1079.e2. doi: 10.1016/j.ahj.2011.09.010. Epub 2011 Nov 8.

  PMID: 22137081 DERIVED

• Gutierrez-Chico JL, Regar E, Nuesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Juni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. doi: 10.1161/CIRCULATIONAHA.110.014514. Epub 2011 Jul 18.

  PMID: 21768536 DERIVED

• Gutierrez-Chico JL, van Geuns RJ, Regar E, van der Giessen WJ, Kelbaek H, Saunamaki K, Escaned J, Gonzalo N, di Mario C, Borgia F, Nuesch E, Garcia-Garcia HM, Silber S, Windecker S, Serruys PW. Tissue coverage of a hydrophilic polymer-coated zotarolimus-eluting stent vs. a fluoropolymer-coated everolimus-eluting stent at 13-month follow-up: an optical coherence tomography substudy from the RESOLUTE All Comers trial. Eur Heart J. 2011 Oct;32(19):2454-63. doi: 10.1093/eurheartj/ehr182. Epub 2011 Jun 9.

  PMID: 21659439 DERIVED

• Stefanini GG, Serruys PW, Silber S, Khattab AA, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, Di Mario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli AL, Gobbens P, Windecker S. The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention). J Am Coll Cardiol. 2011 May 31;57(22):2221-32. doi: 10.1016/j.jacc.2011.01.036.

  PMID: 21616282 DERIVED

• Garg S, Serruys PW, Silber S, Wykrzykowska J, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Van Remortel E, Ronden J, Windecker S. The prognostic utility of the SYNTAX score on 1-year outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial. JACC Cardiovasc Interv. 2011 Apr;4(4):432-41. doi: 10.1016/j.jcin.2011.01.008.

  PMID: 21511223 DERIVED

• Silber S, Windecker S, Vranckx P, Serruys PW; RESOLUTE All Comers investigators. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-year patient-related versus stent-related outcomes from the RESOLUTE All Comers trial. Lancet. 2011 Apr 9;377(9773):1241-7. doi: 10.1016/S0140-6736(11)60395-4. Epub 2011 Apr 1.

  PMID: 21459430 DERIVED

• Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010 Jul 8;363(2):136-46. doi: 10.1056/NEJMoa1004130. Epub 2010 Jun 16.

  PMID: 20554978 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Miraida Weldam
• Organization: Medtronic Bakken Research Center B.V.

miraida.weldam@medtronic.com

+ 31 43 356

Study Officials

• Patrick Serruys, MD

  Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• Sigmund Silber, MD

  Kardiologische Praxis und Praxisklinik, Munich, Germany

  PRINCIPAL INVESTIGATOR

• Stephan Windecker, MD

  University Hospital Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: February 1, 2014
• Last Updated: June 6, 2014
• Results First Posted: May 17, 2011

Record last verified: 2014-05

Locations

CH (1)