Using mechanical thrombectomy to treat acute deep vein thrombosis in the legs

the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine

This study is testing a new procedure to see if it can effectively treat blood clots in the legs for people with acute deep vein thrombosis.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Sex: All
• Sponsor: Chengdu University of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT05356767 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of pharmacomechanical thrombectomy in treating acute deep vein thrombosis (DVT) of the lower extremities. It will enroll approximately 600 patients across 24 centers nationwide from May 2022 to May 2024. The study will assess the patency of lower extremity veins and the incidence of post-thrombotic syndrome (PTS) through various clinical follow-up assessments over a two-year period. Data will be collected on factors influencing the efficacy of the treatment.

Who should consider this trial

Good fit: Ideal candidates are patients who have experienced symptoms of deep vein thrombosis in the lower extremities within the last 14 days and have involvement of the iliac or femoral veins.

Not a fit: Patients with a history of ipsilateral proximal lower limb deep venous thrombosis or those contraindicated for thrombolytic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients suffering from acute deep vein thrombosis and reduce the incidence of post-thrombotic syndrome.

How similar studies have performed: Other studies have shown promising results with pharmacomechanical thrombolysis, but this specific approach in an observational setting is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days)；
2. Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein ;
3. Obtain the informed consent of all patients.

Exclusion Criteria:

1. Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis ;
2. patients who are prohibited from thrombolytic therapy;
3. inferior vena cava compression syndrome；
4. Allergic to heparin, low molecular weight heparin or contrast medium;
5. Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months;
6. Patients who do not want to participate in this trial;
7. Patients with poor compliance, or those who the researchers think are not suitable for selection.

Where this trial is running

Chengdu, Sichuan

• Chunshuihe — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Meng Ye, doctor — Study Principal Investigator RenJi Hospital
• Study coordinator: Chunshui He, doctor

Conditions Pharmacomechanical Thrombolysis; Deep Vein Thrombosis; Pharmacomechanical thrombolysis; Deep vein thrombosis; post-thromboticsyndrome