Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis
Primary Purpose
Deep Venous Thrombosis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Percutaneous mechanical thrombectomy
Sponsored by
About this trial
This is an interventional treatment trial for Deep Venous Thrombosis focused on measuring Deep Venous Thrombosis, Percutaneous Mechanical Thrombectomy
Eligibility Criteria
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.
Sites / Locations
- Beijing Tsinghua Chang Gung HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Percutaneous Mechanical Thrombectomy
Arm Description
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.
Outcomes
Primary Outcome Measures
post-thrombotic syndrome
Clinical scoring was used to compare clinical symptoms and patient findings between the groups at six month and one year after treatment.
Secondary Outcome Measures
complication
complication as death, bleeding, pulmonary embolism, recurrence
Full Information
NCT ID
NCT02959801
First Posted
July 19, 2016
Last Updated
November 6, 2016
Sponsor
Beijing Tsinghua Chang Gung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02959801
Brief Title
Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis
Official Title
Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tsinghua Chang Gung Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis
Keywords
Deep Venous Thrombosis, Percutaneous Mechanical Thrombectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Mechanical Thrombectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous mechanical thrombectomy
Intervention Description
Aspirex catheters(Straub Medical AG, Wangs, Switzerland)
Primary Outcome Measure Information:
Title
post-thrombotic syndrome
Description
Clinical scoring was used to compare clinical symptoms and patient findings between the groups at six month and one year after treatment.
Time Frame
one year
Secondary Outcome Measure Information:
Title
complication
Description
complication as death, bleeding, pulmonary embolism, recurrence
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZHAO Junlai, doctor
Phone
0086-01056119503
Email
zjl_83327@163.com
Facility Information:
Facility Name
Beijing Tsinghua Chang Gung Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102218
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZHAO Junlai, doctor
Phone
008613810277408
Email
zjl_83327@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis
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