Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SM-01, PTA · 1 trial · 1 indication
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 (...
SM-01 is used for the treatment of peripheral vascular diseases, specifically superficial femoral artery disease. It is being studied as a stenting option compared to percutaneous transluminal angioplasty (PTA) in a clinical trial setting.
SM-01 is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker symbol JNJ. The company is conducting clinical research on this device for peripheral vascular disease treatment.
SM-01 is in Phase 3 clinical development. It is an investigational device and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform further development.
SM-01 has one completed Phase 3 trial with the identifier NCT01183117. This trial investigated SM-01 stenting versus PTA for the treatment of superficial femoral artery disease in Japan, enrolling 105 participants aged 20 years and older.
No, SM-01 is not the same as PTA. SM-01 is a stent being tested, while PTA (percutaneous transluminal angioplasty) is a procedure used to open narrowed blood vessels. The clinical trial compares SM-01 stenting against PTA as an active control.