Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATE… (NCT05124184) | Clinical Trial Compass
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, Italy, Spain356 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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
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
4
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
5
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
6
Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years
. 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.
Timeframe: Data were collected retrospectively from health registries, for up to 2 years after index procedure date