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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
History of Changes
  Purpose

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


Condition Intervention Phase
Arteriosclerosis of Arterial Coronary Artery Bypass Graft
 Device: sirolimus-eluting stent
Device: paclitaxel-eluting stent
Device: biodegradable-polymer-based sirolimus-eluting stent
Device: bare metal stents
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized Trial of Drug-eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 610
Study Start Date: November 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DES
drug-eluting stents
 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
Active Comparator: BMS
bare metal stents
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611910

Locations
Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Bad Segeberger Kliniken
Bad Segeberg, Germany
Medizinische Klinik, Klinikum rechts der Isar
Muenchen, Germany, 81675
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
  More Information

No publications provided by Deutsches Herzzentrum Muenchen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. A. Schömig, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00611910     History of Changes
Other Study ID Numbers: GE IDE No. S02707
Study First Received: January 10, 2008
Last Updated: May 12, 2011
Health Authority: Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sirolimus
Everolimus
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013