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NCT00790335 · ClinicalTrials.gov registry record · Phase 3
Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
A Phase 3 study of Venous Thromboembolism and Deep Vein Thrombosis, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 692
- Enrollment target
- 20
- Study locations
NCT00790335: Completed Phase 3 study of Venous Thromboembolism and Deep Vein Thrombosis, sponsored by Washington University School of Medicine.
NCT00790335 is a Phase 3 study of Venous Thromboembolism and Deep Vein Thrombosis that has completed, run by Washington University School of Medicine. The registered enrollment target is 692 participants, below the 6,281-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00790335, a Phase 3 study of Venous Thromboembolism and Deep Vein Thrombosis, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 692 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Recombinant tissue plasminogen activator (rt-PA)
Study Locations (20)
Florida
- Mease Countryside Hospital - Clearwater
- Baptist Cardiac & Vascular Institute - Miami
- Florida Hospital - Orlando
- Florida Hospital-Tampa Division-Pepin Heart Institute and Dr. Kiran C. Patel Research Institute - Tampa
Illinois
- University of Illinois at Chicago - Chicago
- Adventist Midwest Health - Hinsdale
- Southern Illinois University - Springfield
- Central DuPage Hospital - Winfield
California
- St. Joseph Hospital - Orange
- Stanford University Medical Center - Stanford
Connecticut
- Danbury Hospital - Danbury
- Eastern Connecticut Hematology and Oncology Associates - Norwich
Arizona
- Arrowhead Hospital/Phoenix Heart, PLLC - Glendale
Delaware
- Christiana Care Health Systems - Newark
District of Columbia
- Georgetown University Hospital - Washington D.C.
Indiana
- CorVasc - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 692 participants |
| Start Date | 2009-11 |
| Est. Completion | 2017-01 |
| Phase | Phase 3 |
What the finished NCT00790335 record still lists
NCT00790335 is an interventional study that assigns participants to a tested intervention. The registered 692 participants enrollment target is mid-sized for trials with a published cap, below the 6,281-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Venous Thromboembolism appearing as the primary indexed condition, and to 1 intervention - of which Recombinant tissue plasminogen activator (rt-PA) is the first listed.
NCT00790335 names 20 study sites across 12 states, led by Florida, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT00790335 about?
NCT00790335 is a clinical study titled "Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis". 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...
What is the current status of trial NCT00790335?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 692 participants. The study started on 2009-11. Estimated completion is 2017-01.
What conditions does trial NCT00790335 study?
This clinical trial studies the following conditions: Venous Thromboembolism, Deep Vein Thrombosis, Venous Thrombosis, Post-Thrombotic Syndrome, Postphlebitic Syndrome.
What interventions are being tested in trial NCT00790335?
The interventions under investigation include: Recombinant tissue plasminogen activator (rt-PA) (DRUG).
Who is sponsoring clinical trial NCT00790335?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00790335 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00790335's enrollment target sits among peer trials
692 22nd of 47 higher than 26 of 47 other Venous Thromboembolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Thromboembolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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