RecruitingNot ApplicableNCT07622199

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

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)


Sponsor

RenJi Hospital

Enrollment

140 participants

Start Date

Jun 24, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Percutaneous mechanical thrombectomy with profunda femoris vein thrombosis clearance (PMT with PFV-TC) and a procedure called Percutaneous mechanical thrombectomy without profunda femoris vein thrombosis clearance (PMT without PFV-TC) for people with deep vein thrombosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPercutaneous 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 popliteal-profunda communicating vessel approach 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. Successful PFV-TC is defined as the presence of continuous flow from the distal PFV to the CFV, including complete clearance (no residual thrombus) and partial clearance (continuous flow with residual thrombus). Conversely, the absence of continuous flow is defined as failed PFV-TC.

PROCEDUREPercutaneous 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 Indigo catheter (Penumbra Inc, USA). 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, stent implantation is performed.


Locations(1)

Renji hospital

Shanghai, China

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NCT07622199


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