What side effects are associated with this type of intervention?

Common treatments for Deep Vein Thrombosis (DVT) include catheter-directed thrombolysis, percutaneous mechanical thrombectomy, venoplasty, and stenting. These endovascular therapies are generally effective but come with potential side effects. Catheter-directed thrombolysis can lead to major bleeding events, while mechanical thrombectomy and venoplasty may cause vessel injury or perforation. Stenting, although beneficial for maintaining vessel patency, carries risks such as stent migration, thrombosis, and infection. Overall, while these treatments offer significant benefits, they must be carefully managed to mitigate these risks.

What prior FDA approvals exist?

The FDA has approved various endovascular devices and therapies for the treatment of Deep Vein Thrombosis (DVT). These include catheter-directed thrombolysis and mechanical thrombectomy devices, which are used to remove or bypass vascular obstructions. Additionally, drug-eluting stents and balloons, which release antiproliferative drugs like paclitaxel, have been approved to prevent restenosis. Antithrombotic drugs such as enoxaparin, rivaroxaban, and apixaban are also commonly used in conjunction with these procedures to prevent clot formation and improve outcomes.

What other types of research exist?

Promising novel alternatives to Endovascular Therapy for Deep Vein Thrombosis patients in 2024 include: 1) Thrombolytic therapy, which may reduce the risk of post-thrombotic syndrome by decreasing clot burden and preventing vein valve dysfunction. 2) Surgical vein bypass, particularly for patients with severe proximal venous reflux when percutaneous intervention fails. 3) Venous valve reconstruction techniques, although these have had limited success and are less commonly used. 4) Emerging endovascular procedures and technologies that are currently being evaluated in clinical trials.

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Catheter-Directed Therapy for Post-Thrombotic Syndrome (C-TRACT Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Deep Vein Thrombosis (DVT) include anticoagulation therapy, compression therapy, and endovascular therapies. Anticoagulation therapy, using medications like heparin and warfarin, prevents further clot formation and allows the body to gradually dissolve the existing clot. Compression therapy, often involving compression stockings, helps reduce swelling and pain by improving blood flow in the affected limb. Endovascular therapies, such as catheter-directed thrombolysis, percutaneous mechanical thrombectomy, venoplasty, and stenting, involve image-guided techniques to directly remove or bypass vascular obstructions, thereby restoring normal blood flow. These treatments are crucial for DVT patients as they not only alleviate acute symptoms but also prevent serious complications like pulmonary embolism and post-thrombotic syndrome, improving overall quality of life.

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

Must not have

Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned

Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 6 months follow-up

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a blockage in the vein of my leg documented in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I've had a recent deep vein thrombosis (DVT) in the last 3 months.

Select...

I have severe kidney problems or am on dialysis.

Select...

I am under 18 years old.

Select...

I have a large, possibly infected leg ulcer that may show bone or tendon.

Select...

I cannot undergo certain medical procedures due to my current health condition.

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I am expected to live less than 6 months or cannot walk due to reasons other than PTS.

Select...

I have severe leg artery blockage confirmed by a test in the last month.

Select...

I do not have a condition that causes abnormal blood clotting or significant bleeding.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 6 months follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTS Severity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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: 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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Deep Vein Thrombosis (DVT) include anticoagulation therapy, compression therapy, and endovascular therapies. Anticoagulation therapy, using medications like heparin and warfarin, prevents further clot formation and allows the body to gradually dissolve the existing clot. Compression therapy, often involving compression stockings, helps reduce swelling and pain by improving blood flow in the affected limb. Endovascular therapies, such as catheter-directed thrombolysis, percutaneous mechanical thrombectomy, venoplasty, and stenting, involve image-guided techniques to directly remove or bypass vascular obstructions, thereby restoring normal blood flow. These treatments are crucial for DVT patients as they not only alleviate acute symptoms but also prevent serious complications like pulmonary embolism and post-thrombotic syndrome, improving overall quality of life.

Catheter-Based Therapies and Other Management Strategies for Deep Vein Thrombosis and Post-Thrombotic Syndrome.Treatment of deep vein thrombosis of the lower extremities.The role of interventional radiology in the management of deep vein thrombosis.