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

Suspended

• Conditions: Abdominal Aortic Aneurysms
• Interventions: Device: Stent Graft

• Registration Number: NCT02480595
• Lead Sponsor: Lombard Medical

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-24
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-01
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EVAR	Stent Graft	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°

Primary Outcome Measures

Name	Time	Method
Treatment Success	12 months	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

Secondary Outcome Measures

Name	Time	Method
Graft Performance	30 Days to 12 Months	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)

Trial Locations

Locations (37)

Tor Vergata; 🇮🇹 Rome, Italy

Ospeale Maggiore; 🇮🇹 Lodi, Italy

St.Vincenz-Krankenhaus Limburg; 🇩🇪 Limburg, Germany

Ospedale Papa Giovanni 23; 🇮🇹 Bergamo, Italy

Sant'Anna; 🇮🇹 Como, Italy

Ospedale Sant'Andrea delle Fratte; 🇮🇹 Perugia, Italy

Klinikum Rechts der Isar der TU München; 🇩🇪 München, Germany

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Bonifatius Hospital; 🇩🇪 Lingen, Germany

Policlinico San Donato IRCCS; 🇮🇹 San Donato, Italy

University Clinic; 🇪🇸 Barcelona, Spain

Auckland Hospital; 🇳🇿 Auckland, New Zealand

HGU Gregorio Marañon; 🇪🇸 Madrid, Spain

Nottingham University Hospital; 🇬🇧 Nottingham, United Kingdom

H. Universitari Dr. Josep Trueta; 🇪🇸 Girona, Spain

Northwick Park Hospital; 🇬🇧 Harrow, United Kingdom

Royal Bournemouth General Hospital; 🇬🇧 Bournemouth, United Kingdom

Kings College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Mid Essex Hospital - Broomfield; 🇬🇧 Chelmsford, United Kingdom

Norfolk & Norwich University Hospital; 🇬🇧 Norwich, United Kingdom

Royal Preston Hospital; 🇬🇧 Preston, United Kingdom

Ammerland Klinik GmbH; 🇩🇪 Westerstede, Germany

Universitätsklinikum Würzburg; 🇩🇪 Wuerzburg, Germany

Hospital Universitario Puerta del Mar; 🇪🇸 Cádiz, Spain

University Hospital S. Cecilio; 🇪🇸 Granada, 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

Prague University Hospital; 🇨🇿 Prague, Czechia

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Elisabeth-Krankenhaus Essen; 🇩🇪 Essen, Germany

Alfried Krupp Krankenhaus; 🇩🇪 Essen, Germany

University Hospital Halle; 🇩🇪 Halle, Germany

Universitätsklinikum Herzzentrum Köln; 🇩🇪 Köln, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany