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

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.

Study Overview

• Status: Recruiting
• Conditions: End-Stage Renal Disease; AAA - Abdominal Aortic Aneurysm; PAD - Peripheral Arterial Disease
• Intervention / Treatment: Device: GORE® PROPATEN® Vascular Graft; Device: GORE-TEX® Vascular Grafts

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®

• Study Type: Observational
• Enrollment (Estimated): 357

Contacts and Locations

• Study Contact: Name: Daniele Frangioni; Phone Number: +39 342 7736782; Email: dfrangio@wlgore.com

Study Locations

• France
  • Angers, France
    • Completed
    • Centre Hospitalier Unversitaire d'Angers
  • Besançon, France
    • Completed
    • CHRU De Besancon
  • Strasbourg, France
    • Completed
    • Les Hôpitaux Universitaires de Strasbourg
• Italy
  • Ancona, Italy
    • Recruiting
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, SOC Chirurgia Vascolare
    • Contact: Mohammed Reza Ebrahimi, Dr.
  • Milan, Italy
    • Recruiting
    • Unità di Chirurgia Vascolare Ospedale San Raffaele
    • Contact: Roberto Chiesa, Prof.
  • Verona, Italy
    • Recruiting
    • Chirurgia Vascolare Azienda Ospedaliera Universitaria Integrata Verona
    • Contact: Gianfranco Veraldi, Prof.
• Spain
  • Barcelona, Spain, 08003
    • Completed
    • Hospital del Mar
  • Granada, Spain
    • Completed
    • Hospital Clinico Universitario San Cecilio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

General Inclusion Criteria

1. Patient is willing and able to provide written informed consent or consent is waived, according to national and local regulations.
2. Patient was at least 18 years of age at the time of implant.

PAD Cohort Inclusion Criteria 1. 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 at least 5 years before site initiation.

Aortic Aneurysm Cohort Inclusion Criteria

1. 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.

Dialysis Access Cohort Inclusion Criteria 1. 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 at least 2 years before site initiation with the intent to cannulate the registry device.

Exclusion Criteria:

General Exclusion Criteria

1. 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).
2. At the time of treatment, patient had known coagulation disorders, including hypercoagulability, that were not amenable to treatment.
3. Patient was pregnant at the time of treatment.
4. Patient had known or suspected systemic infection or infection at the site of graft implantation at the time of implant.
5. Patient had a separate major interventional or surgical vascular procedure within 30 days prior to treatment. CVC catheter placement would be permitted.
6. Patient is already enrolled in this registry under a different cohort.

PAD Cohort Exclusion Criteria

At the time of treatment, the patient must not have met any of the following criteria:

1. 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.
2. Patient had a stroke or myocardial infarction (MI) within 6 weeks prior to the index procedure.
3. Patient has previous instance of Heparin-induced Thrombocytopenia type 2 or has known hypersensitivity to heparin.
4. Patient required composite bypass for index procedure (graft + significant length of autologous vessel). Autologous "cuffs" or patches are allowed.

Aortic Aneurysm Cohort Exclusion Criteria

At the time of treatment, the patient must not have met any of the following criteria:

1. Patient required emergency surgery due to aneurysm rupture.

Dialysis Access Cohort Exclusion Criteria

At the time of treatment, the patient must not have met any of the following criteria:

1. The patient had a previous documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.
2. The patient was taking maintenance immunosuppressant medication at the time of implant such as rapamycin, mycophenolate or mycophenolic acid, prednisone (> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide.
3. The patient has had a previous instance of Heparin-Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients that have had treatment with GORE® PROPATEN® Vascular Graft; Device: GORE-TEX® Vascular Grafts; Patients that have had treatment with 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; Patients that have had treatment with 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; Patients that have had treatment with GORE® PROPATEN® Vascular Graft; Device: GORE-TEX® Vascular Grafts; Patients that have had treatment with GORE-TEX® Vascular Grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PAD cohort: Primary Safety Outcome: Device-related seroma or infection	5 years
PAD cohort: Primary Performance Outcome: Secondary patency (revascularization)	5 years
Aortic Aneurysm Cohort: Primary Safety Outcome: Survival through 5 years	5 years
Aortic Aneurysm Cohort: Primary Performance Outcome: Primary patency through 5 years	5 years
Dialysis Access Cohort: Primary Safety Outcome: Device-related infection through 2 years	2 years
Dialysis Access Cohort: Useable access circuit (reported as secondary patency) through 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Peripheral Artery Disease Cohort: Limb Salvage through 1 year	1 year
Peripheral Artery Disease Cohort: Amputation-free survival through 1 year	1 year
Peripheral Artery Disease Cohort: Device-related Adverse Events through 1 year	1 year
Peripheral Artery Disease Cohort: Primary Patency through 1 year	1 year
Peripheral Artery Disease Cohort: Device-related infection requiring reoperation through 5 years	5 years
Dialysis Access Cohort: Primary patency through 1 year	1 year
Dialysis Access Cohort: Device-related adverse events through 1 year	1 year

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Atherosclerosis; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Kidney Failure, Chronic; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Diseases
• Other Study ID Numbers: VGP 21-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No