Clinical trial NCT05124184: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PAD - Peripheral Arterial Disease
AAA - Abdominal Aortic Aneurysm
End-Stage Renal Disease
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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®

Eligibility criteria: 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.

Primary outcomes:
measure: PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection
timeFrame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
measure: PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization)
timeFrame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
measure: Aortic Aneurysm Cohort: Primary Safety Outcome: Survival Through 5 Years
timeFrame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
measure: Aortic Aneurysm Cohort: Primary Performance Outcome: Primary Patency Through 5 Years
timeFrame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
measure: Dialysis Access Cohort: Primary Safety Outcome: Device-related Infection Through 2 Years
timeFrame: Data were collected retrospectively from health registries, for up to 2 years after index procedure date
measure: Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years
timeFrame: Data were collected retrospectively from health registries, for up to 2 years after index procedure date
Secondary outcomes:
measure: Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year
timeFrame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
measure: Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year
timeFrame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
measure: Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year
timeFrame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
measure: Peripheral Artery Disease Cohort: Primary Patency Through 1 Year
timeFrame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
measure: Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years
timeFrame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
measure: Dialysis Access Cohort: Primary Patency Through 1 Year
timeFrame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
measure: Dialysis Access Cohort: Device-related Adverse Events Through 1 Year
timeFrame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Unversitaire d'Angers
city: Besançon
country: France
facility: CHRU de Besançon
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, SOC Chirurgia Vascolare
city: Milan
country: Italy
facility: Unità di Chirurgia Vascolare Ospedale San Raffaele
city: Verona
country: Italy
facility: Chirurgia Vascolare Azienda Ospedaliera Universitaria Integrata Verona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Granada
country: Spain
facility: Hospital Clínico Universitario San Cecilio
Study officials:
References: