Preservation of Venous Valvular Function After PMT for Acute DVT (PREFER)

Shanghai Jiao Tong University

Status: Invitation-only

Conditions: Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

Treatments: Other: anticoagulation alone; Device: AngioJet device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05588284

AAL03

Details and patient eligibility

About

To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.

Full description

All patients presenting with symptoms in the lower extremity due to the femoral venous thrombosis involving or not involving iliac and popliteal veins treated with percutaneously pharmacomechanical catheter-directed thrombolysis via AngioJet devices or anticoagulation alone were included in this study.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute symptomatic proximal DVT involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in China. Patients were treated with PCDT via Zelante device (Boston Scientific).

Exclusion criteria

• Participants were excluded if they had symptoms for more than 14 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Pharmacomechanical Catheter-directed Thrombolysis for acute DVT

Experimental group

Description:

AngioJet, Boston Scientific

Treatment:

Device: AngioJet device

anticoagulation alone for acute DVT

Placebo Comparator group

Description:

anticoagulation alone for acute DVT

Treatment:

Other: anticoagulation alone