NCT02480595

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

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Lombard Medical · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	Stent Graft	Endovascular repair of abdominal aortic aneurysm (EVAR)

Timeline

• Start date: 2015-04-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2015-06-24
• Last updated: 2021-11-01

Locations

37 sites across 6 countries: Czechia, Germany, Italy, New Zealand, Spain, United Kingdom