Profunda Femoris Vein Thrombosis Clearance to Improve Outcomes of Endovascular Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two endovascular approaches for acute iliofemoral DVT: (1) endovascular treatment with profunda femoris vein thrombosis clearance and (2) standard percutaneous mechanical thrombectomy without PFV clearance. Eligible adults with recent iliofemoral DVT will undergo rapid thrombus removal using a rapid endovascular device within 14 days of symptom onset. The study aims to see if clearing PFV improves patency of the iliofemoral vein and lowers the risk of post-thrombotic syndrome compared with PMT alone. Prior evidence has shown mixed long-term benefits of thrombus removal; this trial focuses on PFV contribution to outcomes and uses a direct comparative design. Outcomes of interest include vein patency, PTS incidence, hospital stay, and procedure-related safety.

Why it matters

Who can join: the full rules

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 rapid endovascular thrombus removal device;
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.

Where it's running

• Renji hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Qihong Ni
• Email: niqihong1989@163.com
• Phone: +8615801900772

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.