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

Lombard Medical500 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Abdominal Aortic Aneurysms

Interventions

Stent GraftDEVICE

Endovascular repair of abdominal aortic aneurysm (EVAR)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (37)

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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)

Time frame: 30 Days to 12 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 27 more locations