NCT04018846

Brief Summary

The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2022

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2023

Enrollment Period

3.1 years

First QC Date

July 10, 2019

Last Update Submit

September 3, 2024

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery DiseaseRevascularizationGraftVeinArteryLimbAmputation

Outcome Measures

Primary Outcomes (1)

  • The Limb rescue rate one year after a BIOPROTEC graft

    Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years

    Two years

Secondary Outcomes (3)

  • The revascularization permeability rate

    Two years

  • The amputation rate

    Two years

  • Infection resistance rate

    Two years

Interventions

Revascularization using a BIOPROTEC GraftPROCEDURE

It is about a routine care study not changing the usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular Doctor in 1 month, 6 months, 12 months, 18 months and 2 years.

Also known as: BIOPROTEC Vascular Graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Grafted patient with a vascular BIOPROTEC graft in case of a Peripheral artery disease.

You may qualify if:

  • ≥ Eighteen years old.
  • Critical ischemia (Phase 4-6 of Rutherford): no saphenous equipment for the vascular reconstruction; at least one leg axis permeable.

You may not qualify if:

  • Pregnant woman.
  • Patient with an acute ischemia.
  • Patient with an exceeded ischemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cntre Hospitalier René Dubos

Cergy-Pontoise, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Jean-Michel DAVAINE, Dr

    Pitié Salpêtrière Vascular Surgery Service

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 15, 2019

Study Start

September 1, 2018

Primary Completion

October 7, 2021

Study Completion

October 7, 2022

Last Updated

September 19, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)