Altura Post-Market Registry Study: Altitude Registry
Research type
Research Study
Full title
Multi-centre, observational, post-market, real world registry to assess outcomes of patients treated with Altura TM endograft system for endovascular abdominal aortic aneurysm repair.
IRAS ID
222212
Contact name
PAUL DAVID HAYES
Contact email
Sponsor organisation
LOMBARD MEDICAL TECHNOLOGIES PLC
Clinicaltrials.gov Identifier
2017-000604-24, European Clinical Trials Database (EudraCT) number
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
This is a post-market registry study to assess clinical outcomes of the Altura endograft system for endovascular repair of infra-renal abdominal aortic aneurysms in a real-world population. All patients in this study are already planned to be treated with Altura, and this study is simply to capture outcomes in a formalised system.
Abdominal Aortic Aneurysms are focal dilatations of the aorta. The principal risk related to aneurysms is rupture, and this is associated with a high mortality rate. Aneurysms slowly and continually increase in size until reaching a diameter at which the vessel ruptures. When determining at which point a repair is indicated, risk of rupture if the aneurysm is left untreated is measured against risk of perioperative morbidity, including death. Aneurysms can be repaired through an open procedure, or endovascularly, by which the graft used to repair the aorta is introduced through small cuts in the patient’s groin to allow access to the aorta via the patient’s leg vessels under x-ray guidance. This requires a high level of skill, and though an established mode of treatment at many institutions, can result in the patient being exposed to high levels of contrast medium and radiation. The Altura system has been designed to simplify the procedure for repairing aneurysms endovascularly, and is CE-marked. Multiple clinical centres around the world will be involved to include a broad range of experience in a wide geographical span. Enrollment will be of consecutive eligible patients undergoing treatment with the Altura system at each site, and all subjects will be followed procedurally to discharge, and according to institutional standard of care to 5 years’ post implant. It is intended that by studying a real-world patient population in a multi-centre setting will provide an assessment of the generalisability of both approach and system.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0101
Date of REC Opinion
18 Apr 2017
REC opinion
Further Information Favourable Opinion