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Catheter-Directed Therapy for Post-Thrombotic Syndrome (C-TRACT Trial)
N/A
Recruiting
Led By Suresh Vedantham, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ipsilateral iliac vein obstruction documented within 12 months prior to screening by either: Occlusion or >50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or Air plethysmography showing deep venous obstruction of the ipsilateral leg (reduced venous outflow fraction), and ultrasound showing echogenic material in the ipsilateral iliac vein and non-phasic continuous Doppler flow in the ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler flow in the contralateral CFV.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 6 months follow-up
Awards & highlights
C-TRACT Trial Summary
This trial will test if using image-guided, endovascular therapy to treat iliac-obstructive post thrombotic syndrome is effective in reducing disease severity and improving quality of life.
Who is the study for?
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.Check my eligibility
What is being tested?
The C-TRACT Trial is testing whether using image-guided endovascular therapy (EVT), which includes placing stents inside veins of the leg can reduce severity of PTS and improve quality of life for patients with disabling venous obstructions after a deep vein thrombosis.See study design
What are the potential side effects?
Potential side effects from EVT may include pain at the insertion site, bleeding or bruising where catheters are inserted; rare risks involve damage to blood vessels by stents or catheters and allergic reactions to materials used during the procedure.
C-TRACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a blockage in the vein of my leg documented in the last year.
C-TRACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 6 months follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 6 months follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PTS Severity
C-TRACT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Endovascular Therapy - InterventionExperimental Treatment1 Intervention
All subjects (EVT and No-EVT Arms) will receive optimal PTS care. At each Clinical Center, this will be supervised by a physician experienced in managing PTS.
Subjects randomized to EVT will receive the following:
imaging-guided iliac vein stent placement, and
endovenous ablation of refluxing saphenous vein(s), if the patient has truncal reflux and is still symptomatic.
optimal PTS therapy: medical and compression, lifestyle interventions and venous ulcer care
Group II: Non-Endovascular Therapy - ControlActive Control1 Intervention
All subjects will receive optimal PTS care as noted above.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,623 Total Patients Enrolled
4 Trials studying Deep Vein Thrombosis
74,764 Patients Enrolled for Deep Vein Thrombosis
Ontario Clinical Oncology Group (OCOG)OTHER
62 Previous Clinical Trials
41,635 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
692 Patients Enrolled for Deep Vein Thrombosis
Massachusetts General HospitalOTHER
2,931 Previous Clinical Trials
13,198,195 Total Patients Enrolled
5 Trials studying Deep Vein Thrombosis
1,486 Patients Enrolled for Deep Vein Thrombosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe post-thrombotic syndrome in my leg that limits my daily activities.I've had a recent deep vein thrombosis (DVT) in the last 3 months.You have previously had a stent placed in the lower part of the big vein in your abdomen or in the main vein in your leg.You do not have a moderate or severe post-traumatic stress (PTS) disorder.I have severe kidney problems or am on dialysis.Your hemoglobin level is less than 8.0 g/dl, your INR (blood clotting test) can't be corrected and is higher than 3.05, or your platelet count is less than 75,000/ml.You are pregnant, confirmed by a positive pregnancy test.I am under 18 years old.I have a large, possibly infected leg ulcer that may show bone or tendon.I cannot undergo certain medical procedures due to my current health condition.I am expected to live less than 6 months or cannot walk due to reasons other than PTS.You have a strong allergy to iodine contrast that doesn't get better with steroid medication beforehand.I have severe leg artery blockage confirmed by a test in the last month.The doctor cannot find a good vein in the same leg as the problem.I have a blockage in the vein of my leg documented in the last year.I do not have a condition that causes abnormal blood clotting or significant bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Endovascular Therapy - Control
- Group 2: Endovascular Therapy - Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study prominent in North America?
"To make travelling easier for participants, the 21 sites conducting this trial are located across Charlottesville, Plattsburgh, San Francisco and other locations."
Answered by AI
Are patients currently being recruited for this clinical research?
"That is accurate. The clinical trial was first posted on July 2nd, 2018 and was most recently updated on October 11th, 2022. The recruitment goal for this study is 374 patients from 21 different locations."
Answered by AI
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