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)
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Age ≥ 18 years and ≤ 85 years;
• 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);
• Time from symptom onset to endovascular treatment ≤ 14 days;
• Patient receives endovascular treatment with rapid endovascular thrombus removal device;
• Patient provides written informed consent.
Locations
Other Locations
China
Renji hospital
RECRUITING
Shanghai
Contact Information
Primary
Qihong Ni
niqihong1989@163.com
+8615801900772
Time Frame
Start Date: 2026-06-24
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 140
Treatments
Experimental: Endovascular treatment with PFV-TC group
Endovascular treatment with PFV-TC group (experimental group)
Active_comparator: Endovascular treatment without PFV-TC group
Endovascular treatment without PFV-TC group (control group)
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, West China Hospital, First People's Hospital of Hangzhou, Wenzhou Central Hospital, Chengdu University of Traditional Chinese Medicine, Changhai Hospital
Leads: RenJi Hospital