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Completed

NCT Number: NCT04018846

The Future of 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.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cntre Hospitalier René Dubos

Cergy-Pontoise, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Revascularization using a BIOPROTEC Graft

Procedure

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.

Other names: BIOPROTEC Vascular Graft

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

The Future of the Revascularization Using a Bioprotec Graft

Acronym: REVATEC

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jul 15, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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