Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-22 @ 6:57 AM
Study NCT ID:
NCT02480595
Status:
SUSPENDED
Last Update Posted:
2021-11-01
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
Sponsor:
Lombard Medical
Organization:
Study Overview
Official Title:
ARCHYTAS: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
Status:
SUSPENDED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment on hold
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCHYTAS
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: