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OpenTrials
Enrolling by Invitation

NCT Number: NCT05588284

Preservation of Venous Valvular Function After PMT for Acute DVT

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

Enrolling by Invitation

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Key information

Conditions

Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chuzhou People's Hospital, Chuzhou, Anhui, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AngioJet device

Device

A device can be used for thrombus aspiration and thrombolysis.

Other names: Zalente

anticoagulation alone

Other

a medicine for anticoagulation therapy

Other names: rivaroxaban

Primary outcomes

  1. Valvular reflux prevalence

    Time frame: at 12 months after procedure

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

Secondary outcomes

  1. Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)

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

    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.

  2. Patency rate of femopopliteal vein and iliofemoral vein

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

    Patients who presented with patent femopopliteal vein and iliofemoral vein

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Effect of Endovascular Thrombectomy for Femoral Popliteal Vein Thrombosis on Venous Valve Function Maintenance: a Single-center, Single-arm Prospective Observational Study

Acronym: PREFER

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.