Coronary Artery Disease
Conditions
Brief summary
The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.
Interventions
DEVICE4.0 CYPHER Sirolimus-Eluting Coronary Stent
4.0 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 patients minimum 18 years of age 2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia; 3. Target lesions treatable with 4mm stent (visual estimate); 4. Target lesion is 30mm in length (visual estimate); 5. Target lesion stenosis is \>50% and \<100% (visual estimate);
Exclusion criteria
1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment; 2. Has unstable angina classified as Braunwald III B or C, or is having a peri infarction; 3. Documented Left ventricular ejection fraction 25%; 4. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA. | 6 months post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced | 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure |
| Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA. | 6 months post-procedure |
| In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure. | 6 months post-procedure |
| Target lesion revascularization (TLR) at 6 and 9 months post-procedure. | 6 and 9 months post-procedure |
| Target vessel revascularization (TVR) at 6 and 9 months post-procedure. | 6 and 9 months post-procedure |
| Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers. | post-procedure and six months in a subset of approximately 50 patients |
| Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. | End of study |
| Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. | End of Study |
| Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay. | during the hospital stay |
| Target vessel failure (TVF) at 6 and 9 months post-procedure. | 6 and 9 months post-procedure |
Countries
United States
Outcome results
None listed