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NCT04018846 Clinical Trial

The Future of Revascularization Using a Bioprotec Graft

Peripheral Artery Disease Clinical Trial

— REVATEC  

Official title:
The Future of the Revascularization Using a Bioprotec Graft

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04018846
Other study ID # CHRD0518
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date October 7, 2022

Study information
Verified date September 2023
Source Hôpital NOVO
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date October 7, 2022
Est. primary completion date October 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Revascularization using a BIOPROTEC Graft
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.

Locations
Country Name City State
France Cntre Hospitalier René Dubos Cergy-Pontoise

Sponsors (1)
Lead Sponsor Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 The revascularization permeability rate 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 The amputation rate 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 Infection resistance rate 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
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