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

Primary Purpose

Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
sirolimus-eluting stent
paclitaxel-eluting stent
biodegradable-polymer-based sirolimus-eluting stent
bare metal stents
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Herzzentrum Bad Krozingen
  • Bad Segeberger Kliniken
  • Medizinische Klinik, Klinikum rechts der Isar
  • Deutsches Herzzentrum Muenchen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DES

BMS

Arm Description

drug-eluting stents

bare metal stents

Outcomes

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

Secondary Outcome Measures

Myocardial infarction rate
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.
All cause death
Stent thrombosis

Full Information

First Posted
January 10, 2008
Last Updated
May 12, 2011
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00611910
Brief Title
Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions
Acronym
ISAR-CABG
Official Title
Prospective, Randomized Trial of Drug-eluting Stents vs. Bare Metal Stents for the Reduction of Restenosis in Bypass Grafts.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriosclerosis of Arterial Coronary Artery Bypass Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
610 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DES
Arm Type
Experimental
Arm Description
drug-eluting stents
Arm Title
BMS
Arm Type
Active Comparator
Arm Description
bare metal stents
Intervention Type
Device
Intervention Name(s)
sirolimus-eluting stent
Other Intervention Name(s)
Cypher
Intervention Description
due to randomization Cypher stent will be implanted
Intervention Type
Device
Intervention Name(s)
paclitaxel-eluting stent
Other Intervention Name(s)
Taxus
Intervention Description
due to randomization Taxus stent will be implanted
Intervention Type
Device
Intervention Name(s)
biodegradable-polymer-based sirolimus-eluting stent
Other Intervention Name(s)
ISAR-DES, Yukon PC
Intervention Description
due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted
Intervention Type
Device
Intervention Name(s)
bare metal stents
Other Intervention Name(s)
Multilink Vision, Driver, etc.
Intervention Description
Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Myocardial infarction rate
Time Frame
12 months
Title
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
Title
All cause death
Time Frame
12 months
Title
Stent thrombosis
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julinda Mehilli, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
Facility Information:
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Bad Segeberger Kliniken
City
Bad Segeberg
Country
Germany
Facility Name
Medizinische Klinik, Klinikum rechts der Isar
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29724350
Citation
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.
Results Reference
derived
PubMed Identifier
21872918
Citation
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. Erratum In: Lancet. 2012 Jan 14;379(9811):122.
Results Reference
derived

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

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