Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00232739 | Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions | PHASE3 | COMPLETED | 100 | — | — | Sep 1, 2003 | Aug 1, 2009 | Mar 16, 2010 | 1 | United States |
| NCT00231244 | Sirolimus-Eluting BX VELOCITYTM Balloon-Expandable Stent in a Compassionate Use Registry (SECURE) | PHASE3 | COMPLETED | 252 | — | — | Mar 1, 2002 | Nov 1, 2008 | Dec 7, 2009 | 1 | United States |
In-lesion restenosis was defined as over 50 percent diameter stenosis either within the stented segment or within 5 mm proximal or distal to the stent edges at a qualifying follow-up angiogram.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CYPHER Sirolimus-eluting Coronary Stent | DEVICE | 2.25 Cypher Sirolimus-eluting Coronary Stent |
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 ...