Clinical trial NCT02480595: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
Official title: ARCHYTAS: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Abdominal Aortic Aneurysms
Keywords: Abdominal Aortic Aneurysm
AAA
Endovascular
EVAR
Stent
Stent Graft
High Angle
Tortuous
Lead sponsor: Lombard Medical
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The ARCHYTAS Registry will meet objectives only if appropriate patients are enrolled. Patients presenting with AAA who fulfill inclusion criteria and are not ruled out by exclusion criteria will be included. Each investigator will record all potential participants screened for inclusion and document reasons for ineligibility. The implanting physician will consider all relevant medical and nonmedical factors when determining if a particular patient is suitable for inclusion in the Registry. In order to prevent selection bias, sites will be asked to screen and enroll patients consecutively. In circumstances where patients are screened and subsequently enrolled, but for various reasons are not implanted with the Aorfix™ device, only the screening and procedural data will be collected.

Brief summary: The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry designed to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System. Registry data will augment existing data from ongoing and prospective Aorfix™ clinical trials for the purposes of publication, general product development and quality measures.

Detailed description: The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry established by Lombard Medical Ltd. (Lombard) to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°. This indication for Aorfix™ is approved in all territories where this Registry is being operated and this Registry does not seek to collect data on any use of the implant for which full commercial approval does not already exist.

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
2. Intention to electively implant the Aorfix™ Stent Graft System.

Exclusion Criteria:

1. Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU).
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.

Primary outcomes:
measure: Treatment Success
timeFrame: 12 months
Secondary outcomes:
measure: Graft Performance
timeFrame: 30 Days to 12 Months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Prague University Hospital
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Halle
country: Germany
facility: University Hospital Halle
city: Köln
country: Germany
facility: Universitätsklinikum Herzzentrum Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Limburg
country: Germany
facility: St.Vincenz-Krankenhaus Limburg
city: Lingen
country: Germany
facility: Bonifatius Hospital
city: München
country: Germany
facility: Klinikum Rechts der Isar der TU München
city: Westerstede
country: Germany
facility: Ammerland Klinik GmbH
city: Wuerzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni 23
city: Como
country: Italy
facility: Sant'Anna
city: Lodi
country: Italy
facility: Ospeale Maggiore
city: Perugia
country: Italy
facility: Ospedale Sant'Andrea delle Fratte
city: Rome
country: Italy
facility: Tor Vergata
city: San Donato
country: Italy
facility: Policlinico San Donato IRCCS
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Barcelona
country: Spain
facility: University Clinic
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Girona
country: Spain
facility: H. Universitari Dr. Josep Trueta
city: Granada
country: Spain
facility: University Hospital S. Cecilio
city: Madrid
country: Spain
facility: HGU Gregorio Marañon
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Palma de Mallorca
country: Spain
facility: H. Universitari Son Espases
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Santander
country: Spain
facility: H. Marqués de Valdecilla
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth General Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Chelmsford
country: United Kingdom
facility: Mid Essex Hospital - Broomfield
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
affiliation: University Clinic, Barcelona, Spain
name: Vicente Riambau
role: PRINCIPAL_INVESTIGATOR
References: