The Future of Revascularization Using a Bioprotec Graft (REVATEC)

September 8, 2023 updated by: Hôpital NOVO

The Future of the Revascularization Using a Bioprotec Graft

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The BIOPROTEC grafts are controverted: they are useful in some cases, but they are known as frequently broken or thrombosed. However they are always posed in a complicated situations, in a fragile patients who have ever had many of revascularizations or in an infectious state (which is supportive of the pseudoaneurysm and thrombosis) Despite the frequent use of this graft in France, the results have never been published.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Cergy-Pontoise, France
        • Cntre Hospitalier René Dubos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Limb rescue rate one year after a BIOPROTEC graft
Time Frame: Two years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The revascularization permeability rate
Time Frame: Two years
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
The amputation rate
Time Frame: Two years
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
Infection resistance rate
Time Frame: Two years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital NOVO

Investigators

  • Study Director: Jean-Michel DAVAINE, Dr, Pitié Salpêtrière Vascular Surgery Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

October 7, 2021

Study Completion (Actual)

October 7, 2022

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 12, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD0518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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