AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
NCT ID: NCT02480595
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
500 participants
OBSERVATIONAL
2015-04-30
2022-04-30
Brief Summary
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Detailed Description
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The ARCHYTAS Registry data will augment existing data from ongoing and prospective clinical trials with Aorfix™ for the purposes of publication, general product development and quality measures.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EVAR
Patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System for treatment of abdominal aortic and aorto-iliac aneurysms where the aorta in the aneurysm neck is bent through an angle between 0° and 90°
Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
Interventions
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Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Intention to electively implant the Aorfix™ Stent Graft System.
Exclusion Criteria
2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site.
3. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure.
4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.
ALL
No
Sponsors
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Lombard Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Vicente Riambau
Role: PRINCIPAL_INVESTIGATOR
University Clinic, Barcelona, Spain
Locations
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Prague University Hospital
Prague, , Czechia
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Herzzentrum Köln
Cologne, , Germany
Alfried Krupp Krankenhaus
Essen, , Germany
Elisabeth-Krankenhaus Essen
Essen, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
University Hospital Halle
Halle, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
St.Vincenz-Krankenhaus Limburg
Limburg, , Germany
Bonifatius Hospital
Lingen, , Germany
Klinikum Rechts der Isar der TU München
München, , Germany
Ammerland Klinik GmbH
Westerstede, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Ospedale Papa Giovanni 23
Bergamo, , Italy
Sant'Anna
Como, , Italy
Ospeale Maggiore
Lodi, , Italy
Ospedale Sant'Andrea delle Fratte
Perugia, , Italy
Tor Vergata
Rome, , Italy
Policlinico San Donato IRCCS
San Donato, , Italy
Auckland Hospital
Auckland, , New Zealand
University Clinic
Barcelona, , Spain
Hospital Universitario Puerta del Mar
Cadiz, , Spain
H. Universitari Dr. Josep Trueta
Girona, , Spain
University Hospital S. Cecilio
Granada, , Spain
HGU Gregorio Marañon
Madrid, , Spain
Complexo Hospitalario Universitario de Ourense
Ourense, , Spain
H. Universitari Son Espases
Palma de Mallorca, , Spain
Hospital Universitario Donostia
San Sebastián, , Spain
H. Marqués de Valdecilla
Santander, , Spain
Royal Bournemouth General Hospital
Bournemouth, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Mid Essex Hospital - Broomfield
Chelmsford, , United Kingdom
Northwick Park Hospital
Harrow, , United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
Norfolk & Norwich University Hospital
Norwich, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Countries
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Related Links
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Lombard Medical Home Page
Other Identifiers
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ARCHYTAS
Identifier Type: -
Identifier Source: org_study_id