A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Vascutek Ltd.
Summary
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice. Data will be collected both retrospectively and prospectively.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study: All Patients: * Patient meets the minimum age as per local regulations at time of consent * Patient requires treatment with study device(s) according to the IFU(s) * Patient is willing and able to comply with all SOC procedures and study visits * Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively * For prospective emergency patients, retrospec…
Interventions
- DeviceGelsoft Plus Vascular Graft
Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
- DeviceVascular Bypass Graft
Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
- DeviceCardiovascular Patch
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
- DeviceGelweave Vascular Graft
The Gelweave woven polyester vascular graft allows replacement of large sections of arteries and, following anastomosis to the native blood vessel, provides a stable conduit for blood flow.
- DeviceGelweave Valsalva Vascular Graft
This woven polyester graft is designed to match the aortic root anatomy and is implanted to repair or replace a portion of the aorta in case of an aneurysm, dissection or coarctation at the level of the thoracic aorta.
Locations (31)
- University of Colorado AnschutzAurora, Colorado
- University of South Florida - Tampa GeneralTampa, Florida
- Indiana University HealthIndianapolis, Indiana
- Duke UniversityDurham, North Carolina
- East Carolina UniversityGreenville, North Carolina
- University Hospitals Cleveland Medical CenterCleveland, Ohio