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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01183117 | A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease | PHASE3 | COMPLETED | 105 | — | — | Jul 1, 2010 | Aug 1, 2014 | Apr 2, 2015 | 1 | Japan |
The primary endpoint will be freedom from TVF defined as any events of clinical driven (confirmed by duplex ultrasound or angiography) TLR/TVR, procedure failure, amputation of the target lesion's leg, procedure or device related death, occlusion of target lesion, or \> 70% restenosis of target lesion.
| Arm | Type | Description |
|---|---|---|
| SM-01 | EXPERIMENTAL | - |
| PTA | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SM-01 | DEVICE | SM-01 is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery. |
| PTA | DEVICE | balloon angioplasty |
Inclusion Criteria: 1. Age \>= 20 years. 2. Symptomatic leg ischemia by Rutherford Classification (category1, 2, or 3). 3. Lesion length \>= 40 mm to \<= 150 mm. (must be treatable with no more than two SM-01 stents. Overlap should be about 1cm if two stents are used) 4. Reference vessel diameter (...