RECRUITINGOBSERVATIONAL

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)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. willing to sign a consent form signed by patients. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Renji Hospital

Shanghai, Shanghai Municipality, China