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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorRenJi Hospital

About this trial

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 criteria

Qualifiers

Age ≥ 18 years and ≤ 85 years;

Diagnosed with acute iliofemoral DVT involving iliac vein, common femoral vein, and PFV (confirmed by preoperative ultrasound, CT venography, or intraoperative venography);

Time from symptom onset to endovascular treatment ≤ 14 days;

Patient receives endovascular treatment with PMT;

Disqualifiers

Presence of pre-existing PTS in the limb scheduled for treatment, or a history of symptomatic DVT in the same limb within the past 2 years;

Concurrent symptomatic acute DVT involving the iliac vein and/or common femoral vein in the contralateral limb;

Known allergy to heparin, low-molecular-weight heparin, contrast media, or other relevant agents;

Concomitant severe pulmonary embolism with hemodynamic compromise, such as hypoxia or hypotension;

Trial design

Treatments tested in this trial

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

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

RenJi Hospital

Lead sponsor

Wenzhou Central Hospital

Collaborator

West China Hospital

Collaborator

Chengdu University of Traditional Chinese Medicine

Collaborator

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

Collaborator

Changhai Hospital

Collaborator

First People's Hospital of Hangzhou

Collaborator