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

End-Stage Renal Disease Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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® ;

Related Conditions & MeSH terms

• AAA - Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Diseases
• End-Stage Renal Disease
• Kidney Failure, Chronic
• PAD - Peripheral Arterial Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

• NCT number: NCT05124184
• Study type: Observational
• Source: W.L.Gore & Associates
• Contact: Daniele Frangioni
• Phone: +39 342 7736782
• Email: dfrangio@wlgore.com
• Status: Recruiting
• Start date: January 24, 2022
• Completion date: May 31, 2024