Phase 3
Completed N=100
Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Source: ClinicalTrials.gov NCT00232739 ↗Enrolled (actual)
100
Serious AEs
5.5%
Results posted
Feb 2010
Primary outcomePrimary: Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure — 16.9 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced In-lesion Restenosis as Measured by Quantitative Coronary Angiography (QCA) at 6 Months Post-procedure |
16.9 | — |
| SECONDARY Cumulative Percentages of Participants Who Experienced Any Major Adverse Cardiac Events up to Each Scheduled Follow-up |
8.0; 9.0; 11.0; 17.0; 21.0; 27.4 | — |
| SECONDARY Percentage of Participants Who Experienced Any Angiographic In-stent Binary Restenosis up to 6 Months Post-procedure. |
11.7 | — |
| SECONDARY Average In-stent and In-lesion Minimum Lesion Diameters (MLD) at 6 Months Post-procedure. |
1.64; 1.35 | — |
| SECONDARY Cumulative Percentages of Participants Who Experienced Any Target Lesion Revascularization (TLR) up to 6 and 9 Months Post-procedure. |
5.1; 6.1 | — |
| SECONDARY Cumulative Percentages of Participants Who Experienced Any Target Vessel Revascularization (TVR) up to 6 and 9 Months Post-procedure. |
8.1; 10.1 | — |
| SECONDARY Cumulative Percentages of Participants Who Experienced Any Target Vessel Failure (TVF) up to 6 and 9 Months Post-procedure |
11.0; 13.0 | — |
| SECONDARY Average Lumen Volume (mm3) at Post-procedure |
73.34 | — |
| SECONDARY Average Stent Obstruction Volume at Post-procedure |
0.0 | — |
| SECONDARY Average Lumen Volume (mm3) at 6 Months Post-procedure |
70.25 | — |
| SECONDARY Average Stent Obstruction Volume at 6 Months Post-procedure |
3.05 | — |
| SECONDARY Percentage of Participants Who Achieved Lesion Success at Post-procedure |
98.0 | — |
| SECONDARY Percentage of Participants Who Achieved Device Success at Post-procedure |
96.0 | — |
| SECONDARY Percentage of Participants Who Achieved Procedure Success Before Hospital Discharge |
97.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant female patients minimum 18 years of age
- 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;
- Target lesion is 20mm in length (visual estimate);
- Target lesion stenosis is >50% and 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
- Has unstable angina classified as Braunwald III B or C, or is having a peri infarction;
- Documented Left ventricular ejection fraction 25%;
- Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Data sourced from ClinicalTrials.gov (NCT00232739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.