Status:
COMPLETED
Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent
Lead Sponsor:
Medtronic Vascular
Collaborating Sponsors:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, a...
Detailed Description
The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, a...
Eligibility Criteria
Inclusion
- Minimal age 18 years
- Symptomatic coronary artery disease
- Patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
- Presence of one or more coronary artery stenosis \>50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
- Patient indication, lesion length and vessel diameter according to 'Instructions for Use' of study stents
- Patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing EC approved written informed consent.
Exclusion
- Women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
- Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, Zotarolimus, Everolimus, or contrast material
- Participating in other trial before reaching primary endpoint
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
2292 Patients enrolled
Trial Details
Trial ID
NCT00617084
Start Date
April 1 2008
End Date
February 1 2014
Last Update
June 6 2014
Active Locations (1)
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1
Stiftung Inselspital, Department of Cardiology
Bern, Switzerland, CH-3010