Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis
NCT ID: NCT06124768
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
210 participants
OBSERVATIONAL
2021-01-01
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Mixed type DVT treated by PMT through the modified access
Anterograde venography shows patients with mixed type DVT. PMT is performed via ipsilateral distal calf venous access or contralateral femoral access.
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.
Mixed type DVT treated by PMT through the traditional access
Anterograde venography shows patients with mixed type DVT. PMT is performed via ipsilateral popliteal venous access.
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.
Central type DVT treated by PMT
Anterograde venography shows patients with central type DVT. PMT is performed via any access, such as ipsilateral femoral venous access or ipsilateral popliteal venous access.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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First People's Hospital of Hangzhou
OTHER
Chengdu University of Traditional Chinese Medicine
OTHER
RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Ni Qihong, M.D.
Role: STUDY_DIRECTOR
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Locations
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Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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The CODA study
Identifier Type: -
Identifier Source: org_study_id