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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Acute Deep Venous Thrombosis of Femoral Vein (Disorder)
• Intervention / Treatment: Device: AngioJet device; Other: anticoagulation alone

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Chuzhou, Anhui, China, 238000
      • Chuzhou People's Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • Center hospital of Putu
    • Shanghai, Shanghai Municipality, China, 200011
      • Central Hospital of Songjiang
    • Shanghai, Shanghai Municipality, China, 200011
      • North Branch of Shanghai Ninth People's Hospital
    • Shanghai, Shanghai Municipality, China, 200011
      • Shanghai Ninth People's Hospital
    • Shanghai, Shanghai Municipality, China, 201400
      • Fengchen Hospital
  • Zhejiang
    • Taizhou, Zhejiang, China, 218000
      • Taizhou Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacomechanical Catheter-directed Thrombolysis for acute DVT; AngioJet, Boston Scientific	Device: AngioJet device; A device can be used for thrombus aspiration and thrombolysis.; Other Names: Zalente
Placebo Comparator: anticoagulation alone for acute DVT	Other: anticoagulation alone; a medicine for anticoagulation therapy; Other Names: rivaroxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Valvular reflux prevalence	Proportion of patients with femoral venous valve reflux at 1 year after procedure	at 12 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	at 6, 12 and 24 months after procedure

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Kaichuang Ye, MD, PhD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Thiophenes; Rivaroxaban
• Other Study ID Numbers: AAL03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes