Clinical Trials Directory

Trials / Completed

CompletedNCT05124184

Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access

Status
Completed
Phase
—
Study type
Observational
Enrollment
356 (actual)
Sponsor
W.L.Gore & Associates · Industry
Sex
All
Age
18 Years
Healthy volunteers
—

Summary

This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional lifetime for each indication area.

Detailed description

Up to 9 sites in Europe will be required to enroll 353 patients that have had treatment with GORE-TEX® Vascular Grafts or GORE® PROPATEN® Vascular Grafts in the following indication areas: 144 patients in PAD Cohort * 72 Patients with any GORE-TEX® Vascular Graft * 72 Patients with GORE® PROPATEN® 65 patients in Aortic Aneurysm Cohort with GORE-TEX® Vascular Graft 144 patients in Dialysis Access Cohort * 72 patients implanted with any GORE-TEX® Vascular Graft * 72 Patients implanted with Patients with GORE® PROPATEN®

Conditions

Interventions

TypeNameDescription
DEVICEGORE® PROPATEN® Vascular GraftPatients that have had treatment with GORE® PROPATEN® Vascular Graft
DEVICEGORE-TEX® Vascular GraftsPatients that have had treatment with GORE-TEX® Vascular Grafts

Timeline

Start date
2022-01-24
Primary completion
2024-07-22
Completion
2024-07-22
First posted
2021-11-17
Last updated
2025-05-09
Results posted
2025-05-09

Locations

8 sites across 3 countries: France, Italy, Spain

Source: ClinicalTrials.gov record NCT05124184. Inclusion in this directory is not an endorsement.