Abdominal Aortic Aneurysms
Conditions
Keywords
Abdominal Aortic Aneurysm, AAA, Endovascular, EVAR, Stent, Stent Graft, High Angle, Tortuous
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.
Interventions
DEVICEStent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)
Sponsors
Lombard Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Czechia, Germany, Italy, New Zealand, Spain, United Kingdom
Outcome results
None listed