Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions (ISAR-CABG)

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00611910
First received: January 10, 2008
Last updated: May 12, 2011
Last verified: May 2011

January 10, 2008
May 12, 2011
November 2007
March 2011   (final data collection date for primary outcome measure)
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00611910 on ClinicalTrials.gov Archive Site
  • Myocardial infarction rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • All cause death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction rate [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions
Prospective, Randomized Trial of Drug-eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.

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

A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. While there is a plenty of data about the efficacy of DES in complex lesions or diabetics, no randomized data exist about the efficacy of DES in coronary artery bypass graft lesions.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Arteriosclerosis of Arterial Coronary Artery Bypass Graft
  • Device: sirolimus-eluting stent
    due to randomization Cypher stent will be implanted
    Other Name: Cypher
  • Device: paclitaxel-eluting stent
    due to randomization Taxus stent will be implanted
    Other Name: Taxus
  • Device: biodegradable-polymer-based sirolimus-eluting stent
    due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted
    Other Name: ISAR-DES, Yukon PC
  • Device: bare metal stents
    Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist
    Other Names:
    • Multilink Vision
    • Driver
    • etc.
  • Experimental: DES
    drug-eluting stents
    Interventions:
    • Device: sirolimus-eluting stent
    • Device: paclitaxel-eluting stent
    • Device: biodegradable-polymer-based sirolimus-eluting stent
  • Active Comparator: BMS
    bare metal stents
    Intervention: Device: bare metal stents
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, Schömig 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. Epub 2011 Aug 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
610
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00611910
GE IDE No. S02707
Yes
Prof. A. Schömig, Deutsches Herzzentrum Munich
Deutsches Herzzentrum Muenchen
Not Provided
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP