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

Last updated: December 1, 2024
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Thrombosis

Venous Thromboembolism

Claudication

Treatment

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 of contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for mixed type deep venous thrombosis (DVT), and determine whether it can achieve similar therapeutic effects as central type DVT.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Patients who are known to be allergic to heparin, low molecular weight heparin, orcontrast agent;

  2. Women during pregnancy and lactation;

  3. Patients with other diseases that may cause difficulty in the study or significantlyshorten the life expectancy of patients (<6 months);

  4. Patients who are unable or unwilling to participate in the study.

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: Percutaneous mechanical thrombectomy (PMT) by the traditional approach
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
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 of contralateral femoral venous access with the traditional approach for mixed type DVT, and determine whether it can achieve similar therapeutic effects as central type DVT. 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

    Active - Recruiting

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