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.
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
Enrollment
356
Patients that have had treatment with GORE® PROPATEN® Vascular Graft
Patients that have had treatment with GORE-TEX® Vascular Grafts
Centre Hospitalier Unversitaire d'Angers
Angers, France
CHRU de Besançon
Besançon, France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, SOC Chirurgia Vascolare
Ancona, Italy
Unità di Chirurgia Vascolare Ospedale San Raffaele
Milan, Italy
Chirurgia Vascolare Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Hospital del Mar
Barcelona, Spain
Hospital Clínico Universitario San Cecilio
Granada, Spain
PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection
Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site or seroma classified by the registry investigator as primarily related to the registry device.
Time frame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization)
Patency of the study graft with additional or secondary surgical or endovascular procedures to restore flow to the graft after occlusion or stenosis of the graft or its anastomoses. The only exceptions that do not disqualify the graft for secondary patency are procedures performed for disease beyond the graft and its two anastomoses.
Time frame: 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
All Cause survival
Time frame: 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
Patency of the study graft without additional or secondary surgical or endovascular procedures to maintain or restore flow to the graft. The only exceptions that do not disqualify the graft for primary patency are procedures performed for disease beyond the graft and its two anastomoses.
Time frame: 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
Clinical evidence of an infectious process in the direct vicinity of the access site classified by the study investigator as primarily related to the study device.
Time frame: 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
Patency of the study graft from the time of access creation or placement until access abandonment.
Time frame: Data were collected retrospectively from health registries, for up to 2 years after index procedure date
Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year
Freedom from an amputation above the level of the ankle of the index limb
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year
Freedom from an amputation above the level of the ankle of the index limb or all cause death
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year
Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
Peripheral Artery Disease Cohort: Primary Patency Through 1 Year
Patency of the study graft without additional or secondary surgical or endovascular procedures to maintain or restore flow to the graft. The only exceptions that do not disqualify the graft for primary patency are procedures performed for disease beyond the graft and its two anastomoses.
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years
Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site classified by the registry investigator as primarily related to the registry device and required surgical intervention
Time frame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
Dialysis Access Cohort: Primary Patency Through 1 Year
Interval following intervention until the next access thrombosis or repeated intervention.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
Dialysis Access Cohort: Device-related Adverse Events Through 1 Year
Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date