- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05286710
Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb
May 10, 2023 updated by: RenJi Hospital
Clinical Study On The Improvement Of Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb By Primary Popliteal Vein Thrombosis Clearance
Ipsilateral popliteal venous the most common access for pharmacomechanical thrombectomy (PMT) in the treatment of acute deep venous thrombosis (DVT), but the result was not satisfactory.
The investigators adjust the access to improve the thrombus clearance rate and reduce the incidence of post-thrombotic syndrome (PTS).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Acute deep venous thrombosis (DVT) with whole lower limb involved is associated with significant post thrombotic morbidity.
Both of deep venous occlusion and valvar reflux increase the risk for development of post-thrombotic syndrome (PTS).
Early removal of iliofemoral thrombosis by pharmacomechanical thrombectomy (PMT) may reduce the incidence of PTS.
In general, ipsilateral popliteal venous the most common access for PMT.
However, from this approach, it's hard to remove the thrombosis in the distal popliteal vein.
So, the investigators hypothesize that the residual thrombus and slow blood-flow in the in-flow may weakened the efficacy of PMT, and by adjusting vein access approach could improve the thrombus clearance rate and reduce the incidence of PTS for whole leg DVT.
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
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
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18-80 years old;
- Acute DVT with clinical symptoms occurred less than 14 days since the onset of disease;
- DVT with thrombosis involving iliac vein, femoral vein popliteal vein and calf vein;
- Informed consent signed by patients.
Exclusion Criteria:
- Patients with the previous history of the same side of lower-limb DVT;
- Patients with plasma Creatinine level greater than 180umol/L;
- Patients who are contraindicated to thrombolysis;
- Patients with inferior vena cava thrombosis;
- Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
- Patients who have participated in a clinical trial in the past three months;
- Women during pregnancy and lactation
- Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<2 years);
- Patients with autoimmune thrombopathy
- 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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: modified access group
modified access: PMT was performed via distal calf venous access or contralateral femoral access
|
After randomization patients will be allocated to pharmacomechanical thrombectomy (PMT) via ipsilateral popliteal venous approach or to PMT via distal calf venous approach, bail-out contralateral femoral access can be used if puncture was failed in calf vein.
After PMT treatment, residual thrombus was reevaluated by ascending venography.
Catheter-directed thrombolysis (CDT) was conducted if there was residual thrombus.
Stenosis of iliac vein was assessed by multiangle venography and intravascular ultrasound (IVUS) was used if necessary.
Percutaneous balloon angioplasty (PTA) was conducted if there was >50% stenosis of the diameter of the iliac vein.
A stent was placed if the residual stenosis was >50% after PTA treatment.
|
Active Comparator: traditional access group
traditional access: PMT was performed via ipsilateral popliteal venous access
|
After randomization patients will be allocated to pharmacomechanical thrombectomy (PMT) via ipsilateral popliteal venous approach or to PMT via distal calf venous approach, bail-out contralateral femoral access can be used if puncture was failed in calf vein.
After PMT treatment, residual thrombus was reevaluated by ascending venography.
Catheter-directed thrombolysis (CDT) was conducted if there was residual thrombus.
Stenosis of iliac vein was assessed by multiangle venography and intravascular ultrasound (IVUS) was used if necessary.
Percutaneous balloon angioplasty (PTA) was conducted if there was >50% stenosis of the diameter of the iliac vein.
A stent was placed if the residual stenosis was >50% after PTA treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of post-thrombotic syndrome (PTS)
Time Frame: 24 months
|
Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate patency rate
Time Frame: immediately after lonely mechanical thrombectomy
|
Percentage of patency rate immediately after lonely mechanical thrombectomy
|
immediately after lonely mechanical thrombectomy
|
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: post-interventional 24 months
|
Percentage of patency rate of lower limb vein at post-interventional 24 months
|
post-interventional 24 months
|
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score
Time Frame: post-interventional 24 months
|
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score at post-interventional 24 months; The minimum value is 21, and the maximum value is 118.
The higher scores mean a better outcome.
|
post-interventional 24 months
|
Re-intervention rate
Time Frame: within 24 months after operation
|
Percentage of re-intervention rate within 24 months after operation
|
within 24 months after operation
|
Rate of catheter-directed thrombolysis
Time Frame: immediately after interventional surgery
|
Percentage of catheter-directed thrombolysis after mechanical thrombectomy
|
immediately after interventional surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Meng Ye, 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)
October 26, 2022
Primary Completion (Anticipated)
July 31, 2024
Study Completion (Anticipated)
July 31, 2025
Study Registration Dates
First Submitted
March 6, 2022
First Submitted That Met QC Criteria
March 17, 2022
First Posted (Actual)
March 18, 2022
Study Record Updates
Last Update Posted (Actual)
May 12, 2023
Last Update Submitted That Met QC Criteria
May 10, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- The Reformation 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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