NCT06124768

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

Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Deep Vein Thrombosis

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2023-11-09
• Last updated: 2026-02-25

Locations

1 site across 1 country: China