Status:
COMPLETED
A Randomized, Double-blind Study to Assess Paclitaxel-eluting Stents in Treatment of Longer Lesions
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The clinical investigation is an international, prospective, multi-center, double-blind, randomized safety and efficacy trial. The purpose of this study is to evaluate the safety and effectiveness of ...
Detailed Description
The ultimate goal of a paclitaxel eluting stent system is to prevent restenosis by blunting the initial response to stent implant injury and sustaining the arrested response until vascular healing has...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- Patient \>or= 18 years old
- Eligible for percutaneous coronary intervention
- Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
- Acceptable candidate for CABG
- Patient (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- Willing to comply with all specified follow-up evaluations
- Angiographic Inclusion Criteria
- Target lesion located within a single native coronary vessel
- Target lesion randomized to treatment with the study device may be composed of multiple lesions but must be completely coverable by up to 2 study stents (maximum allowable stent length of 48 mm).
- Cumulative target lesion length is \>or= 18 mm and \<or= 40 mm (visual estimate)
- RVD of \>or= 2.5 mm to \<or= 3.75 mm (visual estimate)
- Target lesion diameter stenosis \>or=50% (visual estimate)
- Target lesion is de novo
Exclusion
- General
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT00297804
Start Date
May 1 2002
End Date
February 1 2008
Last Update
April 21 2017
Active Locations (1)
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1
HELIOS Clinic
Siegburg, Germany, 53721