Preservation of Venous Valvular Function After PMT for Acute DVT

NCT ID: NCT05588284

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2025-06-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pharmacomechanical Catheter-directed Thrombolysis for acute DVT

AngioJet, Boston Scientific

Group Type EXPERIMENTAL

AngioJet device

Intervention Type DEVICE

A device can be used for thrombus aspiration and thrombolysis.

anticoagulation alone for acute DVT

anticoagulation alone for acute DVT

Group Type PLACEBO_COMPARATOR

anticoagulation alone

Intervention Type OTHER

a medicine for anticoagulation therapy

Interventions

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AngioJet device

A device can be used for thrombus aspiration and thrombolysis.

Intervention Type DEVICE

anticoagulation alone

a medicine for anticoagulation therapy

Intervention Type OTHER

Other Intervention Names

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Zalente rivaroxaban

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Kaichuang Ye, MD, PhD

Vice professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaichuang Ye, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Chuzhou People's Hospital

Chuzhou, Anhui, China

Site Status

Center hospital of Putu

Shanghai, Shanghai Municipality, China

Site Status

Central Hospital of Songjiang

Shanghai, Shanghai Municipality, China

Site Status

North Branch of Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Fengchen Hospital

Shanghai, Shanghai Municipality, China

Site Status

Taizhou Municipal hospital

Taizhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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AAL03

Identifier Type: -

Identifier Source: org_study_id

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