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

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ClinicalTrials.gov Identifier: NCT02480595
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Lombard Medical

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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysms Device: Stent Graft

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: ARCHYTAS: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
Study Start Date : April 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
EVAR
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
Endovascular repair of abdominal aortic aneurysm (EVAR)
Other Names:
  • Aorfix™ stent
  • Aorfix™ stent graft




Primary Outcome Measures :
  1. Treatment Success [ Time Frame: 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 Outcome Measures :
  1. Graft Performance [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The ARCHYTAS Registry will meet objectives only if appropriate patients are enrolled. Patients presenting with AAA who fulfill inclusion criteria and are not ruled out by exclusion criteria will be included. Each investigator will record all potential participants screened for inclusion and document reasons for ineligibility. The implanting physician will consider all relevant medical and nonmedical factors when determining if a particular patient is suitable for inclusion in the Registry. In order to prevent selection bias, sites will be asked to screen and enroll patients consecutively. In circumstances where patients are screened and subsequently enrolled, but for various reasons are not implanted with the Aorfix™ device, only the screening and procedural data will be collected.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480595


Contacts
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Contact: Lea Doyle (352) 591-0893 lea.doyle@lombardmedical.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
Lombard Medical
Investigators
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Principal Investigator: Vicente Riambau University Clinic, Barcelona, Spain
Additional Information:
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Responsible Party: Lombard Medical
ClinicalTrials.gov Identifier: NCT02480595    
Other Study ID Numbers: ARCHYTAS
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015
Keywords provided by Lombard Medical:
Abdominal Aortic Aneurysm
AAA
Endovascular
EVAR
Stent
Stent Graft
High Angle
Tortuous
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases