Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02959801
Recruitment Status : Unknown
Verified November 2016 by Beijing Tsinghua Chang Gung Hospital.
Recruitment status was:  Recruiting
First Posted : November 9, 2016
Last Update Posted : November 9, 2016
Sponsor:
Information provided by (Responsible Party):
Beijing Tsinghua Chang Gung Hospital

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.

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Procedure: Percutaneous mechanical thrombectomy Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. complication [ Time Frame: one year ]
    complication as death, bleeding, pulmonary embolism, recurrence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959801


Contacts
Layout table for location contacts
Contact: ZHAO Junlai, doctor 0086-01056119503 zjl_83327@163.com

Locations
Layout table for location information
China, Beijing
Beijing Tsinghua Chang Gung Hospital Recruiting
Beijing, Beijing, China, 102218
Contact: ZHAO Junlai, doctor    008613810277408    zjl_83327@163.com   
Sponsors and Collaborators
Beijing Tsinghua Chang Gung Hospital

Layout table for additonal information
Responsible Party: Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier: NCT02959801     History of Changes
Other Study ID Numbers: 12015C1038
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Beijing Tsinghua Chang Gung Hospital:
Deep Venous Thrombosis
Percutaneous Mechanical Thrombectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases