NCT02959801

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

July 19, 2016

Last Update Submit

November 6, 2016

Conditions

Deep Venous Thrombosis

Keywords

Deep Venous ThrombosisPercutaneous Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (1)

  • complication

    one year

Study Arms (1)

Percutaneous Mechanical Thrombectomy

EXPERIMENTAL

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

Interventions

Percutaneous mechanical thrombectomyPROCEDURE

Aspirex catheters(Straub Medical AG, Wangs, Switzerland)

Percutaneous Mechanical Thrombectomy

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • proven acute deep venous thrombosis, less than 21 days and who were referred to the interventional radiology department.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

ZHAO Junlai, doctor

CONTACT

0086-01056119503zjl_83327@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

November 9, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

CN(1)