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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Aortic Aneurysms

Intervention / Treatment
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* Device: Stent Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed abdominal aortic aneurysm with indication for endovascular repair. Intention to electively implant the Aorfix™ Stent Graft System. Exclusion Criteria: Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU). Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure. 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EVAR<br>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° | Device: Stent Graft<br>* Endovascular repair of abdominal aortic aneurysm (EVAR)<br>* Other names: Aorfix™ stent graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal Aortic Aneurysm, AAA, Endovascular, EVAR, Stent, Stent Graft, High Angle, Tortuous