The Efficacy of Three Different Limus Agent-Eluting Stents to Prevent Restenosis

NCT00332397 | Completed Phase 4 DMC

• 1 other identifier: GE IDE No. S02206
• Study Type: interventional
• Target: 1,007
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy of 3 different drug-eluting-stent platforms to reduce coronary artery reblockage after stent implantation

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

• The primary end point of the study is the incidence of binary angiographic restenosis at 6-8 month follow-up angiography, measured by QCA in the in-segment area.

  6-8 months

Secondary Outcomes (4)

• The need of target lesion revascularization defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia.

  9-12 months

• The combined incidence of death or myocardial infarction.

  9-12 months

• In-stent late luminal loss.

  9-12 months

• Incidence of stent thrombosis.

  9-12 months

Study Arms (3)

A

ACTIVE COMPARATOR

Rapamycin-eluting Stent (Cypher)

Device: Rapamycin-eluting Stent

B

ACTIVE COMPARATOR

Zotarolimus-eluting Stent (Endeavor)

Device: Zotarolimus-eluting Stent

C

ACTIVE COMPARATOR

Rapamycin-eluting Stent

Device: Rapamycin-eluting Stent

Interventions

Rapamycin-eluting Stent DEVICE

due to randomization, Cypher stent will be implanted

Also known as: Cypher

A

Zotarolimus-eluting Stent DEVICE

due to randomization, Endeavor stent will be implanted

Also known as: Endeavor

B

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 age 18 ´ presence of ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

You may not qualify if:

• Target lesion located in the left main trunk or bypass graft In-stent restenosis Cardiogenic shock Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance Known allergy to the study medications: aspirin, clopidogrel, zotarolimus, sirolimus, stainless steel, or cobalt alloy Pregnancy (present, suspected or planned) or positive pregnancy test Previous enrollment in this trial Patient's inability to fully cooperate with the study protocol

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

First Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (9)

• Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B, Dirschinger J, Schomig A; Intracoronary Stenting and Angiographic Restenosis--Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial Investigators. Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation. 2006 Jan 17;113(2):273-9. doi: 10.1161/CIRCULATIONAHA.105.575977. Epub 2006 Jan 3.

  PMID: 16391155 BACKGROUND

• Dibra A, Kastrati A, Mehilli J, Pache J, Schuhlen H, von Beckerath N, Ulm K, Wessely R, Dirschinger J, Schomig A; ISAR-DIABETES Study Investigators. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients. N Engl J Med. 2005 Aug 18;353(7):663-70. doi: 10.1056/NEJMoa044372. Epub 2005 Aug 16.

  PMID: 16105990 BACKGROUND

• Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schomig A; investigators of the individualizable durg-eluting Stent System to Abrogate Restenosis Project. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J. 2005 Aug;26(15):1475-81. doi: 10.1093/eurheartj/ehi405. Epub 2005 Jun 23.

  PMID: 15975990 BACKGROUND

• Windecker S, Remondino A, Eberli FR, Juni P, Raber L, Wenaweser P, Togni M, Billinger M, Tuller D, Seiler C, Roffi M, Corti R, Sutsch G, Maier W, Luscher T, Hess OM, Egger M, Meier B. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med. 2005 Aug 18;353(7):653-62. doi: 10.1056/NEJMoa051175. Epub 2005 Aug 16.

  PMID: 16105989 BACKGROUND

• Serruys PW, Ormiston JA, Sianos G, Sousa JE, Grube E, den Heijer P, de Feyter P, Buszman P, Schomig A, Marco J, Polonski L, Thuesen L, Zeiher AM, Bett JH, Suttorp MJ, Glogar HD, Pitney M, Wilkins GT, Whitbourn R, Veldhof S, Miquel K, Johnson R, Coleman L, Virmani R; ACTION investigators. Actinomycin-eluting stent for coronary revascularization: a randomized feasibility and safety study: the ACTION trial. J Am Coll Cardiol. 2004 Oct 6;44(7):1363-7. doi: 10.1016/j.jacc.2004.03.084.

  PMID: 15464314 BACKGROUND

• Kastrati A, Dibra A, Eberle S, Mehilli J, Suarez de Lezo J, Goy JJ, Ulm K, Schomig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials. JAMA. 2005 Aug 17;294(7):819-25. doi: 10.1001/jama.294.7.819.

  PMID: 16106007 BACKGROUND

• Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.

  PMID: 12050336 BACKGROUND

• Byrne RA, Kastrati A, Tiroch K, Schulz S, Pache J, Pinieck S, Massberg S, Seyfarth M, Laugwitz KL, Birkmeier KA, Schomig A, Mehilli J; ISAR-TEST-2 Investigators. 2-year clinical and angiographic outcomes from a randomized trial of polymer-free dual drug-eluting stents versus polymer-based Cypher and Endeavor [corrected] drug-eluting stents. J Am Coll Cardiol. 2010 Jun 8;55(23):2536-43. doi: 10.1016/j.jacc.2010.03.020. Epub 2010 Apr 22.

  PMID: 20417052 DERIVED

• Byrne RA, Mehilli J, Iijima R, Schulz S, Pache J, Seyfarth M, Schomig A, Kastrati A. A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents. Eur Heart J. 2009 Apr;30(8):923-31. doi: 10.1093/eurheartj/ehp044. Epub 2009 Feb 24.

  PMID: 19240066 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Albert Schoemig, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 31, 2006
• First Posted: June 1, 2006
• Study Start: March 1, 2006
• Study Completion: July 1, 2007
• Last Updated: June 17, 2008

Record last verified: 2008-06

Locations

DE (2)