Aneurysm, Aortic Arch, Aortic Diseases, Aortic Root Aneurysm, Aortic Root Dissection, Bypass Extremity Graft, Carotid Artery Injuries, Dissection, Occlusive Vascular Disease
Conditions
Keywords
Vascular Surgery
Brief 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.
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.
Sponsors
Vascutek Ltd.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, retrospective consent is permissible * For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed. Retrospective Patients only: * Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death. * Patient implant date is no more than 5 years prior to study start date.
Exclusion criteria
* Any patient who meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Death | 1 Year | 30 Day or In-Hospital Mortality |
| Graft Leakage | 1 Year | Device Failure: The presence of leakage or excessive bleeding through graft/patch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Endpoints | 1 Year | Device failures, requirement for reintervention or device related adverse events |
| Procedural Endpoints | 1 Year | Rifampicin or heparin soaking, procedure related adverse events |
| Safety Endpoints | 1 Year | Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke |
Countries
Belgium, France, Germany, Hungary, Netherlands, United States
Contacts
CONTACTClinical Study Manager
CONTACTTA UK Clinical Research
Outcome results
None listed