Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis

Sponsor
Beijing Tsinghua Chang Gung Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02959801
Collaborator
(none)
50
1
1
23
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
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 :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. post-thrombotic syndrome [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 [one year]

    complication as death, bleeding, pulmonary embolism, recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tsinghua Chang Gung Hospital Beijing Beijing China 102218

Sponsors and Collaborators

  • Beijing Tsinghua Chang Gung Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier:
NCT02959801
Other Study ID Numbers:
  • 12015C1038
First Posted:
Nov 9, 2016
Last Update Posted:
Nov 9, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Beijing Tsinghua Chang Gung Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2016