Brief 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
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
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®
Study Type
Observational
Primary Outcome
PAD cohort: Primary Safety Outcome: Device-related seroma or infection
Secondary Outcome
Peripheral Artery Disease Cohort: Limb Salvage through 1 year
Condition
PAD - Peripheral Arterial Disease
Intervention
GORE® PROPATEN® Vascular Graft
Study Arms / Comparison Groups
PAD Cohort
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
353
Start Date
January 2022
Completion Date
December 2022
Primary Completion Date
December 2022
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.
Gender
All
Ages
18 Years - N/A
Contacts
, +39 342 7736782, [email protected]
Administrative Informations
NCT ID
NCT05124184
Organization ID
VGP 21-01
Responsible Party
Sponsor
Study Sponsor
W.L.Gore & Associates
Study Sponsor
, ,
Verification Date
November 2021