Status:
COMPLETED
Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to allow treatment with the sirolimus-eluting Bx VELOCITYTM stent in patients with a serious disease or condition for which there is no generally acceptable alternate tr...
Eligibility Criteria
Inclusion
- Male or non-pregnant female patient minimum 18 years of age
- There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon;
- Target lesion is 2.50mm and 3.50mm in diameter (visual estimate);
- Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;
Exclusion
- There is currently another method of treatment for the patient, including coronary artery bypass surgery (CABG) or brachytherapy;
- The study target lesion has definite or possible thrombus present by angiographic criteria.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00231244
Start Date
March 1 2002
End Date
November 1 2008
Last Update
December 7 2009
Active Locations (1)
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1
Scripps Clinic and Research
La Jolla, California, United States, 92037