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Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.

NCT01113892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2020-05-22

Study results available
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Summary

To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

DEVICE

vascular grafts

All devices will be used to treat patients with peripheral arterial occlusive disease

Sponsors & Collaborators

  • Maquet Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Alan Lumsden, MD · The Methodist Hospital Research Institute

  • Nicholas J. Morrissey, MD · NY Presbyterian-Columbia U Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-17
Primary Completion
2012-12-18
Completion
2013-06-04
FDA Device
Yes

Countries

  • United States
  • Czechia
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01113892 on ClinicalTrials.gov