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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 102218
        • Recruiting
        • Beijing Tsinghua Chang Gung Hospital
        • Contact:

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.
Procedure: Percutaneous mechanical thrombectomy
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.

Sponsor

Beijing Tsinghua Chang Gung Hospital

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

Keywords

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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