Preservation of Venous Valvular Function After PMT for Acute DVT

N/AEnrolling By InvitationNCT05588284

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

Interventions

AngioJet deviceDEVICE

A device can be used for thrombus aspiration and thrombolysis.

anticoagulation aloneOTHER

a medicine for anticoagulation therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (7)

Chuzhou People's Hospital

Chuzhou, Anhui, China

Center hospital of Putu

Shanghai, Shanghai Municipality, China

Central Hospital of Songjiang

Shanghai, Shanghai Municipality, China

North Branch of Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Valvular reflux prevalence

Proportion of patients with femoral venous valve reflux at 1 year after procedure

Time frame: at 12 months after procedure

Secondary Outcomes

Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)

Patients who experienced one of the following occurrences in the index leg between the 12 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.

Time frame: at 6, 12 and 24 months after procedure

Patency rate of femopopliteal vein and iliofemoral vein

Patients who presented with patent femopopliteal vein and iliofemoral vein

Time frame: at 6, 12 and 24 months after procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.