About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient is unable or unwilling to comply with the SOC procedures or follow-up regime
Patient is contraindicated per the device IFU
Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure
Trial population
Patients who require treatment, or have already received treatment within the last 5 years, with the following commercially available Terumo Aortic knitted and woven grafts and cardiovascular patches: * Gelsoft Plus - Straights and Bifurcated * Gelsoft Plus - Extra-Anatomical * Cardiovascular Patches - Gelseal, Gelsoft and Thin Wall * Gelweave - Abdominal, Thoracic and Thoracoabdominal * Gelweave - Valsalva This is a non-interventional study and therefore only patients who would normally receive treatment with a Terumo Aortic devices as part of standard treatment at the participating institution can be enrolled.
Trial design
Cohort
Other
Treatments tested in this trial
Gelsoft Plus Vascular Graft
DeviceGelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
Vascular Bypass Graft
DeviceGelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
Cardiovascular Patch
DeviceCardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
Gelweave Vascular Graft
DeviceThe 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.
Gelweave Valsalva Vascular Graft
DeviceThis 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.
Treatment groups
Trial outcomes
Primary outcomes
Operative Death
30 Day or In-Hospital Mortality
Graft Leakage
Device Failure: The presence of leakage or excessive bleeding through graft/patch
Secondary outcomes
Device Endpoints
Device failures, requirement for reintervention or device related adverse events
Procedural Endpoints
Rifampicin or heparin soaking, procedure related adverse events
Safety Endpoints
Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke
Sponsors and contacts
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