Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis

Study Overview
=================
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.

Official Title
-----------------
Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis

Conditions
-----------------
Deep Venous Thrombosis

Intervention / Treatment
-----------------
* Procedure: Percutaneous mechanical thrombectomy


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Mechanical Thrombectomy<br>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<br>* Aspirex catheters(Straub Medical AG, Wangs, Switzerland)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | complication as death, bleeding, pulmonary embolism, recurrence | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Venous Thrombosis, Percutaneous Mechanical Thrombectomy