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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

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