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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01099215 | Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH) | PHASE1 | COMPLETED | 21 | — | — | Apr 30, 2010 | Oct 31, 2012 | Jun 28, 2021 | 3 | France |
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
| Arm | Type | Description |
|---|---|---|
| PVS-10200 | OTHER | Each subject will receive one treatment of PVS-10200 delivered by ultrasound guided injection perivascular to the region of the target lesion within 24 hours of the completed angioplasty and stent placement. |
| Name | Type | Description |
|---|---|---|
| PVS-10200 | BIOLOGICAL | PVS-10200 is composed of allogeneic human aortic endothelial cells cultured in a gelatin matrix. |
Inclusion Criteria: 1. The subject has signed the informed consent document and patient information leaflet. 2. Male and female subject ≥ 18 years of age at the time of consent. 3. If female, the subject is (a) at least 1 year post-menopausal, or (b) surgically sterile, or (c) of child-bearing pote...