Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE)
Phase 3
Completed
- Conditions
- Coronary Artery Disease
- Interventions
- Device: CYPHER Sirolimus-Eluting Coronary Stent
- Registration Number
- NCT00231244
- Lead Sponsor
- Cordis Corporation
- 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 treatment available.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 CYPHER Sirolimus-Eluting Coronary Stent CYPHER Sirolimus-Eluting Coronary Stent
- Primary Outcome Measures
Name Time Method The primary endpoint of this study is a composite of Target Vessel Failure (TVF) defined as target vessel revascularization, myocardial infarction or cardiac death at 30 days, 6mo, 12mo, 2, 3, 4, and 5 years. 30 days, 6mo, 12mo, 2, 3, 4, and 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Scripps Clinic and Research
🇺🇸LaJolla, California, United States