Actively Recruiting
Evaluation of Mechanical Thrombectomy for Acute and Subacute Iliofemoral and Caval Deep Vein Thrombosis in Adults A Retrospective and Prospective Observational Study
Led by IRCCS San Raffaele · Updated on 2025-05-01
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
AI-Summary
What this Trial Is About
This study is an observational, monocentric, retrospective and prospective research aimed at evaluating the feasibility of mechanical thrombectomy in adult patients with symptomatic acute or subacute iliofemoral or caval deep vein thrombosis DVT. The condition is diagnosed with CT scan imaging, and the study follows clinical practice guidelines for patients with proximal DVT in veins such as the inferior vena cava, iliac vein, and femoral veins. Participants will undergo mechanical thrombectomy treatment after receiving anticoagulation therapy with enoxaparin sodium for at least 48 hours prior to the procedure. The access site for the procedure is chosen based on the extent of the blockage, with popliteal vein access used for single limb treatment. After the procedure, catheters are removed, pressure is applied to the insertion site, and pressure bandages are placed on both legs until hospital discharge. Anticoagulation therapy continues until discharge. During the study, participants will have duplex imaging and laboratory tests within 24 hours after treatment completion. Adverse events will be collected as part of the safety monitoring. The primary outcomes measured include the rate of technical success at the end of the procedure and the number of participants experiencing bleeding within 72 hours post-thrombectomy. All visits and procedures are conducted according to normal clinical practice, and the study is expected to run until December 2027.
CONDITIONS
Brief Title
Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems
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