Hidden vein clot cleanup may prevent chronic leg pain

NCT ID NCT07622199

Disease control Sponsor: RenJi Hospital Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This study tests whether removing a blood clot from a specific thigh vein (the profunda femoris vein) during standard treatment for a large leg vein clot can prevent long-term complications like pain and swelling. About 140 adults with recent leg clots will be randomly assigned to get the extra clot removal or standard care alone. The goal is to see if this extra step reduces the chance of developing post-thrombotic syndrome.

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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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2029

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 to 85 years

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: 1. Age ≥ 18 years and ≤ 85 years; 2. Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and the proximal segment (orifice) of PFV (confirmed by preoperative ultrasound, CT venography, or pre-procedural venography); 3. Time from symptom onset to endovascular treatment ≤ 14 days; 4. Patient receives endovascular treatment with PMT; 5. Patient provides written informed consent. Exclusion Criteria: 1. Presence of pre-existing PTS in the limb scheduled for treatment, or a history of symptomatic DVT in the same limb; 2. Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb; 3. Known allergy to heparin, low-molecular-weight heparin, contrast media, or other relevant agents; 4. Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension; 5. Intolerance to endovascular intervention due to concurrent acute systemic illness, severe dyspnea, or other contraindications; 6. Concomitant severe renal insufficiency with creatinine clearance \< 30 ml/min; 7. Presence of active bleeding, severe hepatic insufficiency, bleeding diathesis, or other coagulation disorders; 8. Concomitant severe anemia (hemoglobin \< 8.0 mg/dL) or thrombocytopenia (platelet count \< 80,000/mL); 9. History of subarachnoid hemorrhage, intracranial hemorrhage, intracranial vascular malformation, or intracranial aneurysm; 10. Pregnancy; 11. Presence of other diseases (e.g., advanced malignancy, cardiac insufficiency) with an estimated life expectancy \< 24 months; 12. Participation in another clinical trial of a drug or medical device within the past 1 month that may interfere with the present study; 13. Unwillingness to participate in this trial.

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Conditions

The condition(s) this trial relates to.

Postthrombotic Syndrome venous thromboembolism Venous Thrombosis

As listed by the trial registrant

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

Deep vein thrombosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Hidden vein clot cleanup may prevent chronic leg pain

What the study statuses mean