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PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis

Sponsor: RenJi Hospital • ClinicalTrials.gov ID: NCT07622199

Registry updated: 2026-10-13

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Description

Patients with iliofemoral vein thrombosis are prone to developing post-thrombotic syndrome (PTS). The profunda femoris vein (PFV) is an important inflow of the iliofemoral vein. Profunda femoris vein thrombosis clearance (PFV-TC) may improve the patency of iliofemoral vein and reduce the occurrence of PTS.

Interventions

Endovascular treatment with profunda femoris vein thrombosis clearance (Endovascular treatment with PFV-TC) (Procedure)
Endovascular treatment with PFV-TC group (experimental group): Based on the control group, access is obtained via the contralateral common femoral vein using a crossover technique, or via a popliteal-profunda communicating vessel approach to PFV. The thrombus status of the PFV is assessed, and rapid thrombus removal is performed on the PFV thrombosis.
Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC) (Procedure)
An appropriate puncture approach is selected, including the ipsilateral calf vein, ipsilateral popliteal vein, or ipsilateral femoral vein. Under ultrasound guidance, a vascular sheath is inserted after puncture, and systemic heparinization is performed. Using a guidewire and catheter, the guidewire is advanced antegradely into the inferior vena cava to establish a pathway. Operators may use any device capable of rapid endovascular thrombus removal such as the AngioJet catheter (Boston Scientific, USA) and the Indigo catheter (Penumbra Inc, USA). However, catheter-directed thrombolysis (CDT) alone and the ClotTriever (Inari Medical, USA) is not permitted. After thrombus removal, the outcome is evaluated by venography. If iliac vein stenosis greater than 50% is detected, balloon dilation is performed using a balloon matched to the normal vessel diameter. If residual stenosis remains greater than 50% after balloon dilation, stent implantation is performed.

Eligibility criteria

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.

Conditions

Deep Vein Thrombosis

Locations

Renji hospital — Shanghai, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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