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New hope for chronic leg pain: catheter procedure could reduce Post-Clot disability

NCT ID NCT03250247

Disease control Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a catheter-based procedure can reduce the severity of post-thrombotic syndrome (PTS) — a painful, long-term leg condition that can follow a deep vein clot. About 225 adults with disabling PTS and a blocked iliac vein will receive either the procedure plus standard care or standard care alone. The goal is to see if the procedure improves leg symptoms, quality of life, and ulcer healing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

225 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects must meet BOTH of these Criteria 1. Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease \> or = 3 months duration in a leg with history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator. 2. Ipsilateral iliac vein obstruction documented within 12 months prior to consent by either: 1. Occlusion or \>50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or 2. 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. Exclusion Criteria: Subjects meeting any of these criteria will be excluded. 1. Age less than 18 years 2. Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned 3. Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician 4. Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein 5. Absence of PTS of at least moderate severity 6. Chronic arterial limb ischemia (ankle-brachial index \< 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented) 7. Presence of open venous ulcer \> 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg 8. Inability to tolerate endovascular procedure due to acute illness, or general health 9. Severe allergy to iodinated contrast refractory to steroid premedication 10. Known allergy to stent or catheter components 11. Hemoglobin \< 8.0 g/dl, uncorrectable INR \> 3.0, or platelet count \< 75,000/ml 12. Severe renal impairment (on chronic dialysis or estimated GFR \< 30 ml/min) 13. Disseminated intravascular coagulation or other major bleeding diathesis 14. Pregnancy (positive pregnancy test) 15. Life-expectancy \< 6 months or chronically non-ambulatory for reasons other than PTS 16. Inability to provide informed consent or to comply with study assessments Note - patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion.

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Conditions

The condition(s) this trial relates to.

post-thrombotic syndrome Postthrombotic Syndrome thrombotic disease ulcer of lower limbs Varicose Ulcer venous insufficiency venous thromboembolism Venous Thrombosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Deep vein thrombosis Post-thrombotic syndrome Venous insufficiency Venous leg ulcer Venous reflux Venous stasis

Contacts and locations

Locations

  • Christiana Care Hospital

    Newark, Delaware, 19718, United States

  • Gundersen Health System

    La Crosse, Wisconsin, 54601, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Jobst Vascular Institute

    Toledo, Ohio, 43606, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • New York Presbyterian-Weill Cornell Medicine

    NewYork, New York, 10065, United States

  • New York University Medical Center

    New York, New York, 10003, United States

  • NorthShore University Health System

    Evanston, Illinois, 60201, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Oregon Health & Sciences University

    Portland, Oregon, 97239, United States

  • Rush Medical Center

    Chicago, Illinois, 60612, United States

  • St. Elizabeth's Hospital

    Lincoln, Nebraska, 68510, United States

  • St. Joseph's Vascular Institute

    Orange, California, 92868, United States

  • Staten Island Hospital

    Staten Island, New York, 10305, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UCSF

    San Francisco, California, 94143, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27517, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73014, United States

  • University of Pittsburg

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Vermont Health Network - CVPH

    Plattsburgh, New York, 12901, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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