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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

Official Title

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

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.

Study Type

Observational [Patient Registry]

Primary Outcome

Treatment Success

Secondary Outcome

 Graft Performance

Condition

Abdominal Aortic Aneurysms

Intervention

Stent Graft

Study Arms / Comparison Groups

 EVAR
Description:  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°

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

500

Start Date

April 2015

Completion Date

April 2022

Primary Completion Date

April 2022

Eligibility Criteria

        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.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Vicente Riambau, ,

Location Countries

Czechia

Location Countries

Czechia

Administrative Informations

NCT ID

NCT02480595

Organization ID

ARCHYTAS

Responsible Party

Sponsor

Study Sponsor

Lombard Medical

Study Sponsor

Vicente Riambau, Principal Investigator, University Clinic, Barcelona, Spain

Verification Date

October 2021