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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: Patients with symptomatic peripheral arterial disease in superficial femoral artery lesions in Japan

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Peripheral Arterial Disease

Being tested

GORE® VIABAHN® Endoprosthesis

Medical subject headings

Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• GORE® VIABAHN® EndoprosthesisDevice

  Participants receiving the GORE® VIABAHN® Endoprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Primary Assisted Patency

   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.

   Measured: 12 and 24 months

2. Freedom From Target Lesion Revascularization

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

   Measured: 1, 12 and 24 months

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

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

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

4. Number of Participants With a Stent Fracture

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

   Measured: Month 12, 24, 36, 48 and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted12 Jan 2021
2. Study start25 Aug 2016
3. Primary completion11 Jul 2019
4. Study completion14 Dec 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
• More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.