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

Primary Purpose

Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AngioJet device
anticoagulation alone
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chuzhou People's Hospital
  • Center hospital of Putu
  • Central Hospital of Songjiang
  • North Branch of Shanghai Ninth People's Hospital
  • Shanghai Ninth People's Hospital
  • Fengchen Hospital
  • Taizhou Municipal hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pharmacomechanical Catheter-directed Thrombolysis for acute DVT

anticoagulation alone for acute DVT

Arm Description

AngioJet, Boston Scientific

anticoagulation alone for acute DVT

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Patency rate of femopopliteal vein and iliofemoral vein
Patients who presented with patent femopopliteal vein and iliofemoral vein

Full Information

First Posted
October 18, 2022
Last Updated
February 13, 2023
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05588284
Brief Title
Preservation of Venous Valvular Function After PMT for Acute DVT
Acronym
PREFER
Official Title
Effect of Endovascular Thrombectomy for Femoral Popliteal Vein Thrombosis on Venous Valve Function Maintenance: a Single-center, Single-arm Prospective Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
June 6, 2025 (Anticipated)
Study Completion Date
June 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators
Boston Scientific Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacomechanical Catheter-directed Thrombolysis for acute DVT
Arm Type
Experimental
Arm Description
AngioJet, Boston Scientific
Arm Title
anticoagulation alone for acute DVT
Arm Type
Placebo Comparator
Arm Description
anticoagulation alone for acute DVT
Intervention Type
Device
Intervention Name(s)
AngioJet device
Other Intervention Name(s)
Zalente
Intervention Description
A device can be used for thrombus aspiration and thrombolysis.
Intervention Type
Other
Intervention Name(s)
anticoagulation alone
Other Intervention Name(s)
rivaroxaban
Intervention Description
a medicine for anticoagulation therapy
Primary Outcome Measure Information:
Title
Valvular reflux prevalence
Description
Proportion of patients with femoral venous valve reflux at 1 year after procedure
Time Frame
at 12 months after procedure
Secondary Outcome Measure Information:
Title
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)
Description
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
Title
Patency rate of femopopliteal vein and iliofemoral vein
Description
Patients who presented with patent femopopliteal vein and iliofemoral vein
Time Frame
at 6, 12 and 24 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaichuang Ye, MD, PhD
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chuzhou People's Hospital
City
Chuzhou
State/Province
Anhui
ZIP/Postal Code
238000
Country
China
Facility Name
Center hospital of Putu
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Central Hospital of Songjiang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
North Branch of Shanghai Ninth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Fengchen Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201400
Country
China
Facility Name
Taizhou Municipal hospital
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
218000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Preservation of Venous Valvular Function After PMT for Acute DVT

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