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Prospective, Multicenter Study of the Second Generation Antimicrobial Graft in the Abdominal Position

D

Datascope

Status and phase

Unknown
Phase 4

Conditions

Occlusive Disease of the Abdominal Aorta
Aneurysmal Disease of the Abdominal Aorta

Treatments

Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00824109
HR07-001

Details and patient eligibility

About

The purpose of this prospective trial is to demonstrate the safety and performance of the Second Generation Anti-Microbial vascular graft in the treatment of aneurysmal and occlusive diseases of the abdominal aorta.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Is 18 - 85 years of age
  • Is presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and is eligible for a revascularization with a bifurcated graft
  • Is affiliated with a social welfare organization system
  • Is willing to participate in the clinical evaluation after signature of the informed consent
  • Is able to attend all follow up visits and diagnostics and laboratory exams required by the present protocol

Exclusion criteria

  • Is treated as an emergency
  • Is included in another investigation
  • Is pregnant or lactating, or a woman of childbearing potential unwillint to use an effective form of contraception for the duration of the trial
  • Has a known allergy to the material device used
  • Has previous aorto-iliac bypass or replacement

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Single Arm Study
Other group
Description:
Consecutive patients meeting the selection criteria
Treatment:
Device: Second Generation Anti-Microbial bifurcated vascular graft (InterGard)

Trial contacts and locations

1

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Central trial contact

Philippe Bensimon, Director; Jean-Baptiste Ricco, MD, Professor

Data sourced from clinicaltrials.gov

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