250 Participants Needed

Catheter-Directed Therapy for Post-Thrombotic Syndrome

(C-TRACT Trial)

Recruiting at 34 trial locations
AO
DW
PN
MC
Overseen ByMary Clare Derfler, RN MSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that using dedicated venous stents, which are flexible and have strong support, can improve blood flow in patients with post-thrombotic syndrome, leading to better outcomes and higher patency rates (keeping the vein open).16101112

Who Is on the Research Team?

SV

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

I have severe post-thrombotic syndrome in my leg that limits my daily activities.
I have a blockage in the vein of my leg documented in the last year.
Subjects must meet BOTH of these Criteria

Exclusion Criteria

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.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either endovascular therapy (EVT) or no-EVT, along with optimal PTS care

6 months
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with venous clinical severity scores (VCSS) obtained

6 months

Long-term follow-up

Participants enrolled in earlier protocol versions are followed for an extended period to assess long-term outcomes

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Stents
Trial Overview 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.
How Is the Trial Designed?
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: 1. imaging-guided iliac vein stent placement, and 2. endovenous ablation of refluxing saphenous vein(s), if the patient has truncal reflux and is still symptomatic. 3. 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

St. Luke's Hospital, Kansas City, Missouri

Collaborator

Trials
1
Recruited
250+

Saint Luke's Mid America Heart Institute

Collaborator

Trials
3
Recruited
1,900+

Ontario Clinical Oncology Group (OCOG)

Collaborator

Trials
65
Recruited
42,000+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

St. Luke's Hospital, Kansas City, Missouri

Collaborator

Trials
9
Recruited
12,500+

Published Research Related to This Trial

In a study involving 20 patients with malignant venous obstructions, the use of self-expandable metallic stents successfully relieved symptoms in 16 patients, with complete symptom resolution in 8 cases until death from tumor progression.
The stents were effective in maintaining patency for an average follow-up of three months in 8 patients, demonstrating their utility as a palliative treatment option, despite some complications like thrombotic occlusion and stent migration in a few cases.
[Stent implantation as a palliative therapeutic measure in tumor-induced stenoses of the large veins of the body].Wilhelm, K., Schild, H., Bruch, E., et al.[2016]
Vascular stents have advanced from basic devices to complex drug-delivery systems that can be used in various parts of the body, not just the coronary circulation.
These newer generation stents help prevent complications like neointimal hyperplasia and thrombosis while promoting healthy blood vessel growth, leading to safer and more effective long-term treatments for vascular issues.
Advances in stent technology and drug-eluting stents.Nelken, N., Schneider, PA.[2005]
Metallic stents have significantly improved the treatment of arterial and venous diseases through minimally invasive procedures, enabling the treatment of various lesions that were previously difficult or impossible to address.
The article reviews the different types of stents available, highlighting their role in revolutionizing vascular disease management and enhancing patient outcomes.
Stenting in peripheral vascular disease.Cleveland, TJ., Gaines, P.[2019]

Citations

[Stent implantation as a palliative therapeutic measure in tumor-induced stenoses of the large veins of the body]. [2016]
Advances in stent technology and drug-eluting stents. [2005]
Stenting in peripheral vascular disease. [2019]
Patency rates and clinical outcomes in a cohort of 200 patients treated with a dedicated venous stent. [2019]
Usefulness of non-contrast-enhanced magnetic resonance imaging prior to venous interventions. [2022]
Bioresorbable Scaffold-Based Controlled Drug Delivery for Restenosis. [2020]
The comparative safety of bare-metal and drug-eluting intracoronary stents. [2016]
Hydrophilic surface modification of metallic endoluminal stents. [2019]
9.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Vascular stents: Approaches used to increase their clinical efficacy]. [2018]
Postinterventional antithrombotic management after venous stenting of the iliofemoral tract in acute and chronic thrombosis: A systematic review. [2023]
Systematic Review and Meta-Analysis of Iliofemoral Stenting for Post-thrombotic Syndrome. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Mid- and Long-Term Outcome Comparisons of Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents: A Systematic Review and Meta-analysis. [2022]
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