Catheter-Directed Therapy for Post-Thrombotic Syndrome
(C-TRACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if a procedure called EVT, which uses imaging to guide instruments inside blood vessels, can help patients with severe vein blockages from DIO-PTS. The goal is to see if this treatment can reduce symptoms and improve their quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is catheter-directed therapy using stents generally safe for humans?
Stents, including drug-eluting and bare-metal types, have been used safely in humans, but they can sometimes cause blood clots (thrombosis) or re-narrowing of the blood vessel (restenosis). Newer stent technologies, like bioresorbable scaffolds, aim to reduce these risks by gradually dissolving and releasing medication to help heal the blood vessel.12345
How is catheter-directed therapy for post-thrombotic syndrome different from other treatments?
Catheter-directed therapy for post-thrombotic syndrome is unique because it involves using a catheter to directly deliver treatment to the affected veins, often involving stents that are specifically designed for veins, which are more flexible and have higher radial forces. This approach is minimally invasive and aims to improve blood flow and reduce symptoms by directly targeting the blocked or narrowed veins, unlike traditional treatments that may not address the specific vein obstructions.16789
What data supports the effectiveness of this treatment for post-thrombotic syndrome?
Who Is on the Research Team?
Suresh Vedantham, M.D.
Principal Investigator
Clinical Coordinating Center at Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with severe post-thrombotic syndrome (PTS) due to a history of deep vein thrombosis, who have leg symptoms or ulcers affecting daily life. They must have documented iliac vein blockage and be able to walk. Excluded are those with less than 6 months to live, previous stents in certain veins, severe allergies to materials used in the procedure, pregnant women, inability to consent or follow-up, certain blood conditions, recent DVTs, severe kidney issues or limb ischemia.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either endovascular therapy (EVT) or no-EVT, along with optimal PTS care
Follow-up
Participants are monitored for safety and effectiveness after treatment, with venous clinical severity scores (VCSS) obtained
Long-term follow-up
Participants enrolled in earlier protocol versions are followed for an extended period to assess long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Stents
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
St. Luke's Hospital, Kansas City, Missouri
Collaborator
Saint Luke's Mid America Heart Institute
Collaborator
Ontario Clinical Oncology Group (OCOG)
Collaborator
Massachusetts General Hospital
Collaborator
St. Luke's Hospital, Kansas City, Missouri
Collaborator