- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02959801
Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis
November 6, 2016 updated by: Beijing Tsinghua Chang Gung Hospital
The purpose of this study was to compare the efficacy of Percutaneous mechanical thrombectomy (PMT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The conventional treatment of acute deep vein thrombosis (DVT) is anticoagulation therapy, as recommended in the international guidelines.
Anticoagulation prevents recurrent venous thrombosis, pulmonary embolism, and death.
Early thrombus removal is now considered as the standard of medical care for deep vein thrombosis (DVT).
Early thrombus removal can offer the potential for early restoration of venous patency and preservation of valve function.
Percutaneous mechanical thrombectomy (PMT) uses a number of catheter-based mechanical devices to deliver the thrombolytic agent as well as to produce some combination of thrombus fragmentation, distribution of thrombolytic drugs throughout the thrombus, and/or thrombus aspiration.
The purpose of this study was to compare the efficacy of Percutaneous mechanical thrombectomy (PMT) followed by standard anticoagulant therapy, with anticoagulation therapy alone, for the treatment of acute proximal lower extremity deep vein thrombosis.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
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: ZHAO Junlai, doctor
- Phone Number: 0086-01056119503
- Email: zjl_83327@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 102218
- Recruiting
- Beijing Tsinghua Chang Gung Hospital
-
Contact:
- ZHAO Junlai, doctor
- Phone Number: 008613810277408
- Email: zjl_83327@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 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- proven acute deep venous thrombosis, less than 21 days and who were referred to the interventional radiology department.
Exclusion Criteria:
- presence of subacute or chronic DVT more than 21 days in duration, inability to lie in the prone position required for intervention, terminal systemic disease requiring palliative treatment, active bleeding (from a gastric/duodenal ulcer or the cerebrovascular system), a haemorrhagic stroke within the previous year, an impaired bleeding-clotting profile, and any haemophilic disorder, or pregnancy.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Percutaneous Mechanical Thrombectomy
Percutaneous mechanical thrombectomy(PMT)uses a number of catheter-based mechanical devices to deliver the thrombolytic agent as well as to produce some combination of thrombus fragmentation, distribution of thrombolytic drugs throughout the thrombus, and/or thrombus aspiration.
|
Aspirex catheters(Straub Medical AG, Wangs, Switzerland)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post-thrombotic syndrome
Time Frame: one year
|
Clinical scoring was used to compare clinical symptoms and patient findings between the groups at six month and one year after treatment.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complication
Time Frame: one year
|
complication as death, bleeding, pulmonary embolism, recurrence
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2016
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
July 19, 2016
First Submitted That Met QC Criteria
November 6, 2016
First Posted (Estimate)
November 9, 2016
Study Record Updates
Last Update Posted (Estimate)
November 9, 2016
Last Update Submitted That Met QC Criteria
November 6, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12015C1038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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