Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis

NCT06124768 · tracked via the Priya Life Science China tracker

Sponsor

RenJi Hospital

Phase

Observational

Started

2021-01-01

Last updated

2026-02-25

Condition(s) studied

Deep Vein Thrombosis

Investigational drug(s) / intervention(s)

Percutaneous mechanical thrombectomy (PMT) by the modified approachPercutaneous mechanical thrombectomy (PMT) by the traditional approachTraditional approach

Percutaneous mechanical thrombectomy (PMT) by the modified approach: The modified approach includes the ipsilateral calf venous access and the contralateral femoral venous access. Through contralateral femoral venous access, a hydrophilic guide wire and a catheter will be crossover through the thrombus side to the distal calf vein. The ipsilateral calf venous access will be punctured under the guidance of ascending venography. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \>50% stenosis of the diameter of the iliac vein.

Percutaneous mechanical thrombectomy (PMT) by the traditional approach: The traditional approach will be punctured from the ipsilateral popliteal vein under ultrasound guidance. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \>50% stenosis of the diameter of the iliac vein.

Traditional approach: The approach will be punctured from either the ipsilateral femoral vein or popliteal vein. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \>50% stenosis of the diameter of the iliac vein.

Study summary

The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for iliofemoral deep venous thrombosis (DVT) with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: 1. Age between 18-85 years old; 2. Acute DVT occurred no more than 14 days since the onset of disease; 3. DVT treated by percutaneous mechanical thrombectomy 4. Informed consent signed by patients. Exclusion Criteria: 1. Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent; 2. Women during pregnancy and lactation; 3. Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (\<6 months); 4. Patients who are unable or unwilling to participate in the study.

Primary outcome measure(s)

Incidence of post-thrombotic syndrome — 24-month
Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score

Trial sites (1)

Facility	City	Region	Status
Renji Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06124768 on ClinicalTrials.gov ↗ ← All trials in China