The Future of Revascularization Using a Bioprotec Graft

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-10-07

Brief Summary

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

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Detailed Description

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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BIOPROTEC Vascular Graft

Eligibility Criteria

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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.