Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis

Phase 4

• Conditions: Deep Venous Thrombosis
• Interventions: Procedure: Percutaneous mechanical thrombectomy

• Registration Number: NCT02959801
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-07-19
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-06
• Last Update Submitted: 2016-11-06
• Study First Posted: 2016-11-09
• Last Update Posted: 2016-11-09
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Percutaneous Mechanical Thrombectomy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
complication	one year	complication as death, bleeding, pulmonary embolism, recurrence

Trial Locations

Locations (1)

Beijing Tsinghua Chang Gung Hospital; 🇨🇳 Beijing, Beijing, China