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NOT YET RECRUITING
NCT07622199
NA

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

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis: a Multicenter Randomized Controlled Study (The PROTECT Study)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-07-01

Completion Date

2029-07-30

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

PROCEDURE

Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance (PMT with PFV-TC)

PMT 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 branch of the ipsilateral femoral vein to PFV. The thrombus status of the PFV is assessed, and PMT is performed on the PFV thrombosis. After thrombectomy, venography is performed to evaluate the patency of the PFV, and the thrombus removal grade before and after the procedure is assessed using the following scoring system: 0 points: no thrombus, patent lumen; 1 point: segmental thrombus, partially patent lumen; 2 points: segmental thrombus, occluded lumen; 3 points: fully filled with thrombus, completely occluded lumen.

PROCEDURE

Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC)

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. After the pathway is established, PMT is performed using a mechanical thrombectomy device. Acceptable thrombectomy devices include commercially available mechanical aspiration thrombectomy devices such as the AngioJet catheter (Boston Scientific, USA) and the Acostream catheter (Acotec, China). After thrombectomy, 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, the operator decides whether to place a stent. In cases wh

Locations (1)

Renji hospital

Shanghai, China