Clinical trial NCT00232752: Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Official title: A Multicenter, Non-Randomized Study of the 4.0mm Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA.
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: 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
timeFrame: 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure
measure: Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA.
timeFrame: 6 months post-procedure
measure: In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure.
timeFrame: 6 months post-procedure
measure: Target lesion revascularization (TLR) at 6 and 9 months post-procedure.
timeFrame: 6 and 9 months post-procedure
measure: Target vessel revascularization (TVR) at 6 and 9 months post-procedure.
timeFrame: 6 and 9 months post-procedure
measure: Target vessel failure (TVF) at 6 and 9 months post-procedure.
timeFrame: 6 and 9 months post-procedure
measure: 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.
timeFrame: post-procedure and six months in a subset of approximately 50 patients
measure: 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.
timeFrame: End of study
measure: Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.
timeFrame: End of Study
measure: 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.
timeFrame: during the hospital stay
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Mauri Laura, MD
role: PRINCIPAL_INVESTIGATOR
References: