Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis

Deep Venous Thrombosis Clinical Trial

Official title:

Outcome of Percutaneous Mechanical Thrombectomy to Treat Acute Deep Venous Thrombosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02959801
• Other study ID #: 12015C1038
• Status: Recruiting
• Phase: Phase 4
• First received: July 19, 2016
• Last updated: November 6, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: ZHAO Junlai, doctor
• Phone: 0086-01056119503
• Email: zjl_83327[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Procedure:
• Percutaneous mechanical thrombectomy
Aspirex catheters(Straub Medical AG, Wangs, Switzerland)

Locations

Country	Name	City	State
China	Beijing Tsinghua Chang Gung Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	complication	complication as death, bleeding, pulmonary embolism, recurrence	one year	Yes