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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00232869 | A Study of the SMART Stent in the Treatment SFA Disease. | PHASE2 | COMPLETED | 93 | — | — | Feb 1, 2001 | May 1, 2009 | Feb 4, 2010 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent |
| 2 | ACTIVE_COMPARATOR | SMART™ bare-metal stent |
| Name | Type | Description |
|---|---|---|
| drug-eluting stent | DEVICE | Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent |
| bare-metal stent | DEVICE | SMART™ bare-metal stent |
Inclusion Criteria: 1. One superficial femoral artery presenting \> 70% stenosis(es) or total occlusion 2. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4) Exclusion Criteria: 1. Tissue loss due to ischemic disease (Rutherford category 5 or 6). 2. Tandem lesion requir...