Status:
COMPLETED
Comparative Registry of the PROmus™, ENdeavor™ and CYpher™ Drug Eluting Stents
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to collect real-life data of the Promus™ stent, the Cypher™ stent and the Endeavor™ stent in routine clinical practice, and compare outcomes.
Detailed Description
Boston Scientific is developing the present PROENCY registry to collect real world data with the Promus™ Stent and to compare outcomes to the Cypher™ and Endeavor™ stents. All three stents have recei...
Eligibility Criteria
Inclusion
- All the data collected in this registry will be from patients treated according to the physician's choices, per Product Directions/Instructions for Use, per approved indications and per local standard of care.
- Per PROMUS or CYPHER or Endeavor DFU/IFU
- PROMUS Indications:
- PROMUS™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length 28 mm) with a reference vessel diameter of 2.5 mm - 4.0 mm.
- CYPHER Indications:
- CYPHER SELECT Sirolimus-eluting Coronary Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo and in-stent restenotic lesions (length 30 mm) in native coronary arteries with a reference vessel diameter of 2.25 mm to 5.00 mm.
- Endeavor Indications:
- Endeavor Stent is indicated for improving coronary luminal diameter and reducing restenosis in patients with symptomatic ischemic heart disease in de novo coronary artery lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of \< 27 mm.
Exclusion
- PROMUS Contraindications:
- Patients in whom anti-platelet and / or anti-coagulant therapy is contraindicated.
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- Patients with a known hypersensitivity or contraindication to everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro - polymers may have an allergic reaction to this implant; therefore, the implant is not recommended for such patients.
- CYPHER Contraindications:
- Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- Transplant patients.
- Endeavor Contraindications:
- Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drugs such as ABT-578, rapamycin, tacrolimus, sirolimus or similar drugs or any other analogue or derivative, cobalt, chromium, nickel, molybdenum, or contrast media.
- Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
- Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
1934 Patients enrolled
Trial Details
Trial ID
NCT00930878
Start Date
February 1 2008
End Date
March 1 2010
Last Update
February 3 2017
Active Locations (1)
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1
Kerckhoff-Klinik GmbH
Bad Nauheim, Hesse, Germany, 61231