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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00442364 | Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt | PHASE2 | COMPLETED | 60 | — | — | Mar 1, 2007 | Aug 1, 2009 | Apr 21, 2021 | 7 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Polidocanol (1%) Microfoam (Varisolve) |
| Name | Type | Description |
|---|---|---|
| Polidocanol (1%) Microfoam (Varisolve) | DRUG | Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein. |
| Endovenous Microfoam Occlusion | PROCEDURE | Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries. |
Inclusion Criteria: * Males and females aged 18 to 60 with severe varicose veins, CEAP classes 3, 4 and 5 (CEAP is a classification and grading system for chronic venous disease) * Saphenofemoral junction (SFJ) incompetence. Retrograde blood flow in the GSV, greater than or equal to 1.0 second demo...