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

Korábbi kezelés

• Patient had a separate major interventional or surgical vascular procedure within 30 days prior to treatment. CVC catheter placement would be permitted.
• 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 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.

Más betegség

• At the time of treatment, patient had known coagulation disorders, including hypercoagulability, that were not amenable to treatment.
• Patient had known or suspected systemic infection or infection at the site of graft implantation at the time of implant.

Egyéb

• 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).
• Patient was pregnant at the time of treatment.
• 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 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:

• 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
• 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.