PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Vascutek Ltd.
2,000 participants
Feb 17, 2021
OBSERVATIONAL
Conditions
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
Inclusion Criteria10
- 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 Criteria3
- 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
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Interventions
Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
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.
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)
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NCT04545502