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

Last updated: July 22, 2024
Sponsor: W.L.Gore & Associates
Overall Status: Completed

Phase

N/A

Condition

Aneurysm

Peripheral Arterial Occlusive Disease

Vascular Diseases

Treatment

GORE-TEX® Vascular Grafts

GORE® PROPATEN® Vascular Graft

Clinical Study ID

NCT05124184
VGP 21-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

General Inclusion Criteria

  1. Patient is willing and able to provide written informed consent or consent iswaived, 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 AAAor TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft,GORE-TEX® Stretch Vascular Graft at least 5 years before site initiation. Researchdevice could have been used to replace or bypass either a diseased visceral branchor 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

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 aftertreatment, patients who live far away from the clinical site and are not availableto share follow-up data performed locally).

  2. At the time of treatment, patient had known coagulation disorders, includinghypercoagulability, 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 graftimplantation at the time of implant.

  5. Patient had a separate major interventional or surgical vascular procedure within 30days 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 targetartery at the anticipated site of the proximal or distal anastomosis within 30 daysprior to the index procedure. Use of PTA or stenting during the index procedure ispermitted.

  2. Patient had a stroke or myocardial infarction (MI) within 6 weeks prior to the indexprocedure.

  3. Patient has previous instance of Heparin-induced Thrombocytopenia type 2 or hasknown hypersensitivity to heparin.

  4. Patient required composite bypass for index procedure (graft + significant length ofautologous 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 centralvenous stenosis via imaging technique.

  2. The patient was taking maintenance immunosuppressant medication at the time ofimplant 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 Design

Total Participants: 358
Treatment Group(s): 2
Primary Treatment: GORE-TEX® Vascular Grafts
Phase:
Study Start date:
January 24, 2022
Estimated Completion Date:
July 22, 2024

Study 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®

Connect with a study center

  • Centre Hospitalier Unversitaire d'Angers

    Angers,
    France

    Site Not Available

  • CHRU de Besançon

    Besançon,
    France

    Site Not Available

  • Les Hôpitaux Universitaires de Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, SOC Chirurgia Vascolare

    Ancona,
    Italy

    Site Not Available

  • Unità di Chirurgia Vascolare Ospedale San Raffaele

    Milan,
    Italy

    Site Not Available

  • Chirurgia Vascolare Azienda Ospedaliera Universitaria Integrata Verona

    Verona,
    Italy

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Clínico Universitario San Cecilio

    Granada,
    Spain

    Site Not Available

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