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

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.

Conditions

• Deep Vein Thrombosis

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 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.

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 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.

Sponsors & Collaborators

• Wenzhou Central Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Chengdu University of Traditional Chinese Medicine

  collaborator OTHER

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• First People's Hospital of Hangzhou

  collaborator OTHER

• RenJi Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-24

Primary Completion

2029-06-30

Completion

2029-12-31

Countries

• China

Study Locations