PAD - Peripheral Arterial DiseaseNCT05124184
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
An observational study of PAD - Peripheral Arterial Disease and AAA - Abdominal Aortic Aneurysm, run by W.L.Gore & Associates at 8 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm, End-Stage Renal Disease
- What is being tested?
- GORE® PROPATEN® Vascular Graft and GORE-TEX® Vascular Grafts
- Type of treatment
- Medical device
- How many people
- 356 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 24 Jan 2022to 22 Jul 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- General Inclusion Criteria
- 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.
- 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.
Who cannot join
- General Exclusion Criteria
- 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.
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- 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:
- 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.
- 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:
- The patient had a previous documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.
- 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.
- The patient has had a previous instance of Heparin-Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
France3 sites
Centre Hospitalier Unversitaire d'Angers
Angers
CHRU de Besançon
Besançon
Les Hôpitaux Universitaires de Strasbourg
Strasbourg
Italy3 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, SOC Chirurgia Vascolare
Ancona
Unità di Chirurgia Vascolare Ospedale San Raffaele
Milan
Chirurgia Vascolare Azienda Ospedaliera Universitaria Integrata Verona
Verona
Spain2 sites
Hospital del Mar
Barcelona, 08003
Hospital Clínico Universitario San Cecilio
Granada
About this study
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.
Read the 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®
- Conditions
- PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm, End-Stage Renal Disease
- Being tested
- GORE® PROPATEN® Vascular Graft, GORE-TEX® Vascular Grafts
- Medical subject headings
- Aortic Aneurysm, Abdominal, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® PROPATEN® Vascular GraftDevice
Patients that have had treatment with GORE® PROPATEN® Vascular Graft
GORE-TEX® Vascular GraftsDevice
Patients that have had treatment with GORE-TEX® Vascular Grafts
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: GORE® PROPATEN® Vascular Graft; Device: GORE-TEX® Vascular Grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Freedom from an amputation above the level of the ankle of the index limb
Measured: 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
Freedom from an amputation above the level of the ankle of the index limb or all cause death
Measured: 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
Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device
Measured: 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
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.
Measured: 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
Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site classified by the registry investigator as primarily related to the registry device and required surgical intervention
Measured: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
Dialysis Access Cohort: Primary Patency Through 1 Year
Interval following intervention until the next access thrombosis or repeated intervention.
Measured: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
Dialysis Access Cohort: Device-related Adverse Events Through 1 Year
Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device
Measured: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start24 Jan 2022
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PAD - Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124184
- Sponsor's protocol ID
- VGP 21-01
- Status last verified
- Apr 2025
- First submitted
- 5 Nov 2021
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No