- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06124768
Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis
November 6, 2023 updated by: RenJi Hospital
Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)
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.
Study Overview
Status
Recruiting
Conditions
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 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.
Study Type
Observational
Enrollment (Estimated)
210
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ni Qihong, M.D.
- Phone Number: +8615801900772
- Email: niqihong1989@163.com
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200127
- Recruiting
- RenJi Hospital
-
Contact:
- Ni Qihong, M.D.
- Phone Number: +86 15801900772
- Email: niqihong1989@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with acute lower limb deep venous thrombosis (DVT) treated by percutaneous mechanical thrombectomy (PMT).
The symptoms of DVT should no more than 14 days.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate patency rate
Time Frame: Immediately after lonely percutaneous mechanical thrombectomy
|
Percentage of patency rate immediately after lonely percutaneous mechanical thrombectomy
|
Immediately after lonely percutaneous mechanical thrombectomy
|
Incidence of post-thrombotic syndrome
Time Frame: 24-month
|
Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
|
24-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of catheter-directed thrombolysis
Time Frame: Immediately after interventional surgery
|
Percentage of catheter-directed thrombolysis after mechanical thrombectomy
|
Immediately after interventional surgery
|
Total time of interventional surgery
Time Frame: Immediately after interventional surgery
|
Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)
|
Immediately after interventional surgery
|
Total dosage of urokinase
Time Frame: Immediately after interventional surgery
|
Total dosage measured by units of urokinase used for procedure
|
Immediately after interventional surgery
|
Patency rate of lower limb vein
Time Frame: 24-month
|
Percentage of patency rate of lower limb vein evaluated by ultrasound
|
24-month
|
Incidence of post-thrombotic syndrome
Time Frame: 12-month
|
Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score
|
12-month
|
Re-intervention rate
Time Frame: 24-month
|
Percentage of re-intervention rate for the same limb
|
24-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Ni Qihong, M.D., Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2027
Study Registration Dates
First Submitted
November 6, 2023
First Submitted That Met QC Criteria
November 6, 2023
First Posted (Estimated)
November 9, 2023
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- The CODA study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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