Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions

NCT00611910 | Completed Phase 4 DMC

• 1 other identifier: GE IDE No. S02707
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting

Conditions

Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

• The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation

  12 months

Secondary Outcomes (4)

• Myocardial infarction rate

  12 months

• Need of target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia.

  12 months

• All cause death

  12 months

• Stent thrombosis

  12 months

Study Arms (2)

DES

EXPERIMENTAL

drug-eluting stents

Device: sirolimus-eluting stent; Device: paclitaxel-eluting stent; Device: biodegradable-polymer-based sirolimus-eluting stent

BMS

ACTIVE COMPARATOR

bare metal stents

Device: bare metal stents

Interventions

sirolimus-eluting stent DEVICE

due to randomization Cypher stent will be implanted

Also known as: Cypher

DES

paclitaxel-eluting stent DEVICE

due to randomization Taxus stent will be implanted

Also known as: Taxus

DES

biodegradable-polymer-based sirolimus-eluting stent DEVICE

due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted

Also known as: ISAR-DES, Yukon PC

DES

bare metal stents DEVICE

Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist

Also known as: Multilink Vision, Driver, etc.

BMS

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 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in CABG
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
• In women with childbearing potential a negative pregnancy test is mandatory

You may not qualify if:

• Cardiogenic shock
• Target lesion located in the native coronary vessels.
• In-stent restenosis of CABG
• Target lesion located at internal mammary artery graft or free arterial graft
• Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
• Known allergy to the study medications: clopidogrel, rapamycin, paclitaxel, stainless steel.
• Inability to take clopidogrel for at least 6 months.
• 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 (4)

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Bad Segeberger Kliniken

Bad Segeberg, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Medizinische Klinik, Klinikum rechts der Isar

München, 81675, Germany

Location

Related Publications (2)

• Colleran R, Kufner S, Mehilli J, Rosenbeiger C, Schupke S, Hoppmann P, Joner M, Mankerious N, Fusaro M, Cassese S, Abdel-Wahab M, Neumann FJ, Richardt G, Ibrahim T, Schunkert H, Laugwitz KL, Kastrati A, Byrne RA; ISAR-CABG Investigators. Efficacy Over Time With Drug-Eluting Stents in Saphenous Vein Graft Lesions. J Am Coll Cardiol. 2018 May 8;71(18):1973-1982. doi: 10.1016/j.jacc.2018.03.456.

  PMID: 29724350 DERIVED

• Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, Fusaro M, Laugwitz KL, Massberg S, Neumann FJ, Richardt G, Schomig A, Kastrati A; Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts? (ISAR-CABG) Investigators. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): a randomised controlled superiority trial. Lancet. 2011 Sep 17;378(9796):1071-8. doi: 10.1016/S0140-6736(11)61255-5. Epub 2011 Aug 26.

  PMID: 21872918 DERIVED

Study Officials

• Julinda Mehilli, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

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: January 10, 2008
• First Posted: February 11, 2008
• Study Start: November 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 13, 2011

Record last verified: 2011-05

Locations

DE (4)