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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Deep Vein Thrombosis

Treatments: Procedure: Percutaneous mechanical thrombectomy (PMT) by the modified approach; Procedure: Traditional approach; Procedure: Percutaneous mechanical thrombectomy (PMT) by the traditional approach

Study type: Observational

Funder types: Other

Identifiers

NCT06124768

The CODA study

Details and patient eligibility

About

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.

Full description

Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach for iliofemoral DVT with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

210 participants in 3 patient groups

Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the modified access

Description:

Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral distal calf venous access or contralateral femoral access.

Treatment:

Procedure: Percutaneous mechanical thrombectomy (PMT) by the modified approach

Iliofemoral DVT with distal popliteal vein thrombosis treated by PMT through the traditional access

Description:

Anterograde venography shows patients with iliofemoral DVT with distal popliteal vein thrombosis. PMT is performed via ipsilateral popliteal venous access.

Treatment:

Procedure: Percutaneous mechanical thrombectomy (PMT) by the traditional approach

Iliofemoral DVT without distal popliteal vein thrombosis treated by PMT

Description:

Anterograde venography shows patients with iliofemoral DVT without distal popliteal vein thrombosis. PMT is performed via any access, such as ipsilateral femoral venous access or ipsilateral popliteal venous access.

Treatment:

Procedure: Traditional approach