Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutaneous mechanical thrombectomy (PMT) by the modified approach, Percutaneous mechanical thrombectomy (PMT) by the traditional approach, Traditional approach.
- Who it may be relevant to
- Registry conditions: Deep Vein Thrombosis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)
Overview
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.
Interventions
- 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 mechan - 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 ball - 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
Primary outcome measures
- Incidence of post-thrombotic syndrome [Time frame: 24-month]
Secondary outcome measures (6)
- Rate of catheter-directed thrombolysis [Time frame: Immediately after interventional surgery]
- Total time of interventional surgery [Time frame: Immediately after interventional surgery]
- Total dosage of urokinase [Time frame: Immediately after interventional surgery]
- Patency rate of lower limb vein [Time frame: 24-month]
- Incidence of post-thrombotic syndrome [Time frame: 12-month]
- Re-intervention rate [Time frame: 24-month]
Eligibility criteria
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 criteria
- Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
- Women during pregnancy and lactation;
- Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<6 months);
- Patients who are unable or unwilling to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Renji Hospital — Shanghai
Identifiers
NCT: NCT06124768 · The CODA study