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Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial
The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.
Details
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 692 |
| Start date | 2009-11 |
| Completion | 2017-01 |
Conditions
- Deep Vein Thrombosis
- Venous Thrombosis
- Postphlebitic Syndrome
- Venous Thromboembolism
- Post Thrombotic Syndrome
Interventions
- Recombinant tissue plasminogen activator (rt-PA)
Primary outcomes
- Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) — Between 6 and 24 months after randomization
Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Countries
United States