Coronary Artery Disease
Conditions
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.
Interventions
CYPHER Sirolimus-Eluting Coronary Stent
Sponsors
Cordis US Corp.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant female patient minimum 18 years of age 2. There is no alternative treatment for this patient as determined by the treating physician and an uninvolved cardiac surgeon; 3. Target lesion is 2.50mm and 3.50mm in diameter (visual estimate); 4. Target lesion is 45mm in length (visual estimate), treated with a maximum of three 18 mm stents;
Exclusion criteria
1. There is currently another method of treatment for the patient, including coronary artery bypass surgery (CABG) or brachytherapy; 2. The study target lesion has definite or possible thrombus present by angiographic criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed