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OpenTrials
Completed

NCT Number: NCT04706273

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)

This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.

Completed

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Kansai Rousai

Amagasaki, Hyōgo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic peripheral arterial disease in superficial femoral artery lesions

Treatment and study plan

GORE® VIABAHN® Endoprosthesis

Device

Participants receiving the GORE® VIABAHN® Endoprosthesis

Primary outcomes

  1. Primary Assisted Patency

    Time frame: 12 and 24 months

    Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.

  2. Freedom From Target Lesion Revascularization

    Time frame: 1, 12 and 24 months

    Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.

  3. Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies

    Time frame: Procedure day, 1, 12, 24, 36, 48 and 60 months

    The number and proportion of the subjects for whom the occurrence of serious adverse events were reported.

  4. Number of Participants With a Stent Fracture

    Time frame: Month 12, 24, 36, 48 and 60

    The number and proportion of stent fracture as assessed by Core lab

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2022
First posted
Jan 12, 2021
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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