A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts
Vascutek Ltd.
Summary
Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.
Description
Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Minimum age as per local regulations * Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft * Ability to provide informed consent o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB/EC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) or use of a Legally Authorized Representative (LAR). * Willingness to comply with the registry protocol * Willingness to adhere to follow-up visits…
Interventions
- DeviceThoracic
Implant of a Relay stent graft system
- DeviceAbdominal
Implant with an Anaconda or Treo Stent graft system
- DeviceCustom Device
Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
- DeviceIlliac Artery
Implant with an Anaconda Iliac leg only
Locations (58)
- Long Beach Memorial Medical CenterLong Beach, California
- University of Colorado Anschutz Medical CampusAurora, Colorado
- UC Health Memorial Hospital CenterColorado Springs, Colorado
- Yale UniversityNew Haven, Connecticut
- MedStar Washington Hospital CenterWashington D.C., District of Columbia
- University of FloridaGainesville, Florida