Status:
COMPLETED
Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Arteriosclerosis of Arterial Coronary Artery Bypass Graft
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT00611910
Start Date
November 1 2007
End Date
March 1 2011
Last Update
May 13 2011
Active Locations (4)
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1
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
2
Bad Segeberger Kliniken
Bad Segeberg, Germany
3
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
4
Medizinische Klinik, Klinikum rechts der Isar
München, Germany, 81675