Preservation of Venous Valvular Function After PMT for Acute DVT

Launched by SHANGHAI NINTH PEOPLE'S HOSPITAL AFFILIATED TO SHANGHAI JIAO TONG UNIVERSITY · Oct 18, 2022

Keywords

ClinConnect Summary

This study is looking at two ways to treat a new, provocative blood clot in the deep veins of the leg (near the thigh and knee). Researchers want to know if removing the clot with a catheter-based, drug-assisted procedure (pharmacomechanical thrombectomy using AngioJet) helps protect the vein valves and keep blood flowing normally better than standard blood thinning alone. The main question they will answer is whether this approach reduces valve problems (valve reflux) in the femoral vein about a year after treatment. They will also track longer-term issues such as the development of post-thrombotic symptoms (like swelling, pain, skin changes, or ulcers) and how well the leg veins stay open over time.

Who can join and what to expect: Adults aged 18 to 80 with a new, symptomatic proximal deep vein thrombosis (involving the femoral and/or popliteal veins, and possibly the iliac veins) that started within the last 14 days may be eligible at seven centers in China. Participants may be randomly assigned to receive either the pharmacomechanical thrombectomy plus clot-busting treatment or anticoagulation alone (usual blood thinner therapy). If enrolled, you’ll have follow-up visits at about 6, 12, and 24 months, including imaging tests to check vein openness and valve function and to monitor symptoms. The study plans to enroll about 100 people and is sponsored by Shanghai Ninth People’s Hospital with collaboration from Boston Scientific. Results are not yet available, and enrollment was ongoing as of mid-2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with acute symptomatic proximal DVT involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in China. Patients were treated with PCDT via Zelante device (Boston Scientific).
• Exclusion Criteria:
• • Participants were excluded if they had symptoms for more than 14 days.