Phase
Condition
Aneurysm
Peripheral Arterial Occlusive Disease
Vascular Diseases
Treatment
GORE-TEX® Vascular Grafts
GORE® PROPATEN® Vascular Graft
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
General Inclusion Criteria
Patient is willing and able to provide written informed consent or consent iswaived, 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
- Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAAor TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft,GORE-TEX® Stretch Vascular Graft at least 5 years before site initiation. Researchdevice could have been used to replace or bypass either a diseased visceral branchor 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
Exclusion Criteria:
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 aftertreatment, patients who live far away from the clinical site and are not availableto share follow-up data performed locally).
At the time of treatment, patient had known coagulation disorders, includinghypercoagulability, 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 graftimplantation at the time of implant.
Patient had a separate major interventional or surgical vascular procedure within 30days prior to treatment. CVC catheter placement would be permitted.
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 targetartery at the anticipated site of the proximal or distal anastomosis within 30 daysprior to the index procedure. Use of PTA or stenting during the index procedure ispermitted.
Patient had a stroke or myocardial infarction (MI) within 6 weeks prior to the indexprocedure.
Patient has previous instance of Heparin-induced Thrombocytopenia type 2 or hasknown hypersensitivity to heparin.
Patient required composite bypass for index procedure (graft + significant length ofautologous 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:
- 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 centralvenous stenosis via imaging technique.
The patient was taking maintenance immunosuppressant medication at the time ofimplant 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.
Study Design
Study Description
Connect with a study center
Centre Hospitalier Unversitaire d'Angers
Angers,
FranceSite Not Available
CHRU de Besançon
Besançon,
FranceSite Not Available
Les Hôpitaux Universitaires de Strasbourg
Strasbourg,
FranceSite Not Available
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, SOC Chirurgia Vascolare
Ancona,
ItalySite Not Available
Unità di Chirurgia Vascolare Ospedale San Raffaele
Milan,
ItalySite Not Available
Chirurgia Vascolare Azienda Ospedaliera Universitaria Integrata Verona
Verona,
ItalySite Not Available
Hospital del Mar
Barcelona, 08003
SpainSite Not Available
Hospital Clínico Universitario San Cecilio
Granada,
SpainSite Not Available
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