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

Phase

N/A

Condition

Deep Vein Thrombosis

Venous Thrombosis

Venous Thromboembolism

Treatment

Traditional approach

Percutaneous mechanical thrombectomy (PMT) by the traditional approach

Percutaneous mechanical thrombectomy (PMT) by the modified approach

Clinical Study ID

NCT06124768

The CODA study

Ages 18-85
All Genders

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 Criteria

Inclusion

Inclusion Criteria:

Age between 18-85 years old;
Acute DVT occurred no more than 14 days since the onset of disease;
DVT treated by percutaneous mechanical thrombectomy
Informed consent signed by patients.

Exclusion

Exclusion Criteria:

Patients who are known to be allergic to heparin, low molecular weight heparin, orcontrast agent;
Women during pregnancy and lactation;
Patients with other diseases that may cause difficulty in the study or significantlyshorten the life expectancy of patients (<6 months);
Patients who are unable or unwilling to participate in the study.

Study Design

Traditional approach

January 01, 2021

October 31, 2027

Study 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.

Connect with a study center

Renji Hospital
Shanghai, Shanghai 200127
China
Site Not Available
Renji Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200127
China
Active - Recruiting

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