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The Future of Revascularization Using a Bioprotec Graft (REVATEC)

H

Hôpital NOVO

Status

Completed

Conditions

Peripheral Artery Disease

Treatments

Procedure: Revascularization using a BIOPROTEC Graft

Study type

Observational

Funder types

Other

Identifiers

NCT04018846
CHRD0518

Details and patient eligibility

About

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

Full 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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Véronique DA COSTA; Maryline DELATTRE

Data sourced from clinicaltrials.gov

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