Clinical trial NCT00232739: Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Official title: A Multicenter, Non-Randomized Study of the 2.25mm 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 restenosis in patients with de novo native coronary artery lesions.

Detailed description: This is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. The study is designed to evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in patients with de novo native coronary artery lesions. A total of 100 patients will be entered in the study. Patients who meet the eligibility criteria will be enrolled into the study. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 6 months. Approximately 50 patients will be required to have an intravascular ultrasound (IVUS) procedure at baseline and at the 6-month angiographic follow-up.

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 lesion is 20mm in length (visual estimate);
4. 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: Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure
timeFrame: From post-procedure to 6 months
Secondary outcomes:
measure: Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up
timeFrame: From post-procedure to 4 years
measure: Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure.
timeFrame: From post-procedure to 6 months
measure: Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure.
timeFrame: From post-procedure to 6 months
measure: Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure.
timeFrame: From post-procedure to 6 months and 9 months
measure: Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure.
timeFrame: From post-procedure to 6 months and 9 months follow-up
measure: Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure
timeFrame: From post-procedure to 6 months and 9 months follow-up
measure: Average Lumen Volume (mm3) at Post-procedure
timeFrame: At Post-procedure
measure: Average Stent Obstruction Volume at Post-procedure
timeFrame: At post-procedure
measure: Average Lumen Volume (mm3) at 6 Months Post-procedure
timeFrame: From post-procedure to 6 months
measure: Average Stent Obstruction Volume at 6 Months Post-procedure
timeFrame: From post-procedure to 6 months
measure: Percentage of Participants Who Achieved Lesion Success at Post-procedure
timeFrame: At post-procedure
measure: Percentage of Participants Who Achieved Device Success at Post-procedure
timeFrame: At post-procedure
measure: Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge
timeFrame: From post-procedure to hospital discharge
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
affiliation: Lenox Hill Hospital
name: Sriram Iyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moses JW, Nikolsky E, Mehran R, Cambier PA, Bachinsky WB, Leya F, Kuntz RE, Popma JJ, Schleckser P, Wang H, Cohen SA, Leon MB; SIRIUS 2.25 Investigators. Safety and efficacy of the 2.25-mm sirolimus-eluting Bx Velocity stent in the treatment of patients with de novo native coronary artery lesions: the SIRIUS 2.25 trial. Am J Cardiol. 2006 Dec 1;98(11):1455-60. doi: 10.1016/j.amjcard.2006.06.047. Epub 2006 Oct 13.