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Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis

NCT ID: NCT02959801

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Deep Venous Thrombosis

Keywords

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Deep Venous Thrombosis Percutaneous Mechanical Thrombectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Percutaneous mechanical thrombectomy

Intervention Type PROCEDURE

Aspirex catheters(Straub Medical AG, Wangs, Switzerland)

Interventions

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Percutaneous mechanical thrombectomy

Aspirex catheters(Straub Medical AG, Wangs, Switzerland)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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ZHAO Junlai, doctor

Role: CONTACT

Phone: 0086-01056119503

Email: [email protected]

Facility Contacts

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ZHAO Junlai, doctor

Role: primary

Other Identifiers

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12015C1038

Identifier Type: -

Identifier Source: org_study_id