AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft

Abdominal Aortic Aneurysms Clinical Trial

— ARCHYTAS  

Official title:

ARCHYTAS: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02480595
• Other study ID #: ARCHYTAS
• Status: Suspended
• Start date: April 2015
• Est. completion date: April 2022

Study information

• Verified date: October 2021
• Source: Lombard Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 500
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)

Locations

Country	Name	City	State
Czechia	Prague University Hospital	Prague
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Alfried Krupp Krankenhaus	Essen
Germany	Elisabeth-Krankenhaus Essen	Essen
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	University Hospital Halle	Halle
Germany	Universitätsklinikum Herzzentrum Köln	Köln
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	Wuerzburg
Italy	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
New Zealand	Auckland Hospital	Auckland
Spain	University Clinic	Barcelona
Spain	Hospital Universitario Puerta del Mar	Cádiz
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
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Lombard Medical

Countries where clinical trial is conducted

Czechia,  Germany,  Italy,  New Zealand,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success	Defined as freedom from the following: Sac expansion > 5mm; Type I and III endoleaks requiring re-intervention; Rupture; Conversion to open surgery; Stent graft migration > 10 mm; Stent graft occlusion	12 months
Secondary	Graft Performance	Defined as: Stent graft migration > 10mm (12 months); Stent graft patency (12 months); Stent graft endoleaks (30 days and 12 months); Aneurysm-related secondary procedure (12 months); Adverse device effects (12 months); Technical observations (12 months); Aneurysm-related mortality (12 Months); All-cause mortality (30 days and 12 months); Major Adverse Events (MAEs) (30 days)	30 Days to 12 Months

External Links

•   Lombard Medical Home Page