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

NCT05124184 | Completed Results

• 1 other identifier: VGP 21-01
• Study Type: observational
• Target: 356
• Locations: 3 countries
• Sites: 8

Brief 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.

Conditions

PAD - Peripheral Arterial Disease; AAA - Abdominal Aortic Aneurysm; End-Stage Renal Disease

Outcome Measures

Primary Outcomes (6)

• PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection

  Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site or seroma classified by the registry investigator as primarily related to the registry device.

  Data were collected retrospectively from health registries, for up to 5 years after index procedure date

• PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization)

  Patency of the study graft with additional or secondary surgical or endovascular procedures to restore flow to the graft after occlusion or stenosis of the graft or its anastomoses. The only exceptions that do not disqualify the graft for secondary patency are procedures performed for disease beyond the graft and its two anastomoses.

  Data were collected retrospectively from health registries, for up to 5 years after index procedure date

• Aortic Aneurysm Cohort: Primary Safety Outcome: Survival Through 5 Years

  All Cause survival

  Data were collected retrospectively from health registries, for up to 5 years after index procedure date

• Aortic Aneurysm Cohort: Primary Performance Outcome: Primary Patency Through 5 Years

  Patency of the study graft without additional or secondary surgical or endovascular procedures to maintain or restore flow to the graft. The only exceptions that do not disqualify the graft for primary patency are procedures performed for disease beyond the graft and its two anastomoses.

  Data were collected retrospectively from health registries, for up to 5 years after index procedure date

• Dialysis Access Cohort: Primary Safety Outcome: Device-related Infection Through 2 Years

  Clinical evidence of an infectious process in the direct vicinity of the access site classified by the study investigator as primarily related to the study device.

  Data were collected retrospectively from health registries, for up to 2 years after index procedure date

• Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years

  Patency of the study graft from the time of access creation or placement until access abandonment.

  Data were collected retrospectively from health registries, for up to 2 years after index procedure date

Secondary Outcomes (7)

• Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year

  Data were collected retrospectively from health registries, for up to 1 year after index procedure date

• Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year

  Data were collected retrospectively from health registries, for up to 1 year after index procedure date

• Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year

  Data were collected retrospectively from health registries, for up to 1 year after index procedure date

• Peripheral Artery Disease Cohort: Primary Patency Through 1 Year

  Data were collected retrospectively from health registries, for up to 1 year after index procedure date

• Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years

  Data were collected retrospectively from health registries, for up to 5 years after index procedure date

Study Arms (3)

PAD Cohort

Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft

Device: GORE® PROPATEN® Vascular Graft; Device: GORE-TEX® Vascular Grafts

AAA Cohort

Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft

Device: GORE-TEX® Vascular Grafts

Dialysis Access Cohort

Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft

Device: GORE® PROPATEN® Vascular Graft; Device: GORE-TEX® Vascular Grafts

Interventions

GORE® PROPATEN® Vascular Graft DEVICE

Patients that have had treatment with GORE® PROPATEN® Vascular Graft

Dialysis Access Cohort; PAD Cohort

GORE-TEX® Vascular Grafts DEVICE

Patients that have had treatment with GORE-TEX® Vascular Grafts

AAA Cohort; Dialysis Access Cohort; PAD Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of three cohorts. Patients that have had treatment with GORE-TEX® Vascular Grafts or GORE® PROPATEN® Vascular Graft for PAD, aortic aneurysms, or dialysis access are eligible for consideration for enrollment in the registry. Patients will be selected from hospital database.

You may qualify if:

• Patient is willing and able to provide written informed consent or consent is waived, according to national and local regulations.
• Patient was at least 18 years of age at the time of implant.
• \. Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft at least 5 years before site initiation. Research device could have been used to replace or bypass either a diseased visceral branch or the aorta itself.

You may not qualify if:

• Patient was not available for follow up (on-site or remotely) at the clinical site, with the exception of death (e.g., patient lost to follow-up immediately after treatment, patients who live far away from the clinical site and are not available to share follow-up data performed locally).
• At the time of treatment, patient had known coagulation disorders, including hypercoagulability, that were not amenable to treatment.
• Patient was pregnant at the time of treatment.
• Patient had known or suspected systemic infection or infection at the site of graft implantation at the time of implant.
• Patient had a separate major interventional or surgical vascular procedure within 30 days prior to treatment. CVC catheter placement would be permitted.
• Patient is already enrolled in this registry under a different cohort.
• At the time of treatment, the patient must not have met any of the following criteria:
• Patient had percutaneous transluminal angioplasty (PTA) or stenting of the target artery at the anticipated site of the proximal or distal anastomosis within 30 days prior to the index procedure. Use of PTA or stenting during the index procedure is permitted.
• Patient had a stroke or myocardial infarction (MI) within 6 weeks prior to the index procedure.
• Patient has previous instance of Heparin-induced Thrombocytopenia type 2 or has known hypersensitivity to heparin.
• Patient required composite bypass for index procedure (graft + significant length of autologous vessel). Autologous "cuffs" or patches are allowed.
• At the time of treatment, the patient must not have met any of the following criteria:
• \. Patient required emergency surgery due to aneurysm rupture.
• At the time of treatment, the patient must not have met any of the following criteria:
• The patient had a previous documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (8)

Centre Hospitalier Unversitaire d'Angers

Angers, France

Location

CHRU de Besançon

Besançon, France

Location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, SOC Chirurgia Vascolare

Ancona, Italy

Location

Unità di Chirurgia Vascolare Ospedale San Raffaele

Milan, Italy

Location

Chirurgia Vascolare Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clínico Universitario San Cecilio

Granada, Spain

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Austin Phillips
• Organization: W. L. Gore & Associates

agphilli@wlgore.com

+1 928 864 3641

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: January 24, 2022
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); IT (3); FR (3)