CompletedNot Applicable

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

France, Italy356 participantsStarted 2022-01-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.
✕. Patient is already enrolled in this registry under a different cohort.
✕. 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.

What they're measuring

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

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

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

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

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

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

Trial details

NCT IDNCT05124184

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-07-22

Results submitted2025-02-14

View on ClinicalTrials.gov More PAD - Peripheral Arterial Disease trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.
✕. Patient is already enrolled in this registry under a different cohort.
✕. 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.