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

October 25, 2021 updated by: Lombard Medical

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 12808
        • Prague University Hospital
  • Germany
      • Berlin, Germany, 13353
        • Charite - Universitatsmedizin Berlin
      • Essen, Germany, 45131
        • Alfried Krupp Krankenhaus
      • Essen, Germany, 45134
        • Elisabeth-Krankenhaus Essen
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt
      • Halle, Germany, 06120
        • University Hospital Halle
      • Köln, Germany, 50924
        • Universitätsklinikum Herzzentrum Köln
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Limburg, Germany, 65549
        • St.Vincenz-Krankenhaus Limburg
      • Lingen, Germany, 49808
        • Bonifatius Hospital
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München
      • Westerstede, Germany, 26655
        • Ammerland Klinik GmbH
      • Wuerzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • Italy
      • Bergamo, Italy, 21100
        • Ospedale Papa Giovanni 23
      • Como, Italy, 22020
        • Sant'Anna
      • Lodi, Italy, 26900
        • Ospeale Maggiore
      • Perugia, Italy, 06100
        • Ospedale Sant'Andrea delle Fratte
      • Rome, Italy
        • Tor Vergata
      • San Donato, Italy, 20097
        • Policlinico San Donato IRCCS
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland Hospital
  • Spain
      • Barcelona, Spain, 8036
        • University Clinic
      • Cádiz, Spain, 11009
        • Hospital Universitario Puerta del Mar
      • Girona, Spain, 17007
        • H. Universitari Dr. Josep Trueta
      • Granada, Spain, 18012
        • University Hospital S. Cecilio
      • Madrid, Spain, 28007
        • Hgu Gregorio Maranon
      • Ourense, Spain, 32005
        • Complexo Hospitalario Universitario de Ourense
      • Palma de Mallorca, Spain, 07120
        • H. Universitari Son Espases
      • San Sebastián, Spain, 20014
        • Hospital Universitario Donostia
      • Santander, Spain, 39008
        • H. Marques De Valdecilla
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth General Hospital
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Chelmsford, United Kingdom, CM1 7ET
        • Mid Essex Hospital - Broomfield
      • Harrow, United Kingdom, HA1 3UJ
        • Northwick Park Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital NHS Foundation Trust
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk & Norwich University Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospital
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 Days to 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lombard Medical

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (ESTIMATE)

June 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARCHYTAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abdominal Aortic Aneurysms

Clinical Trials on Stent Graft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe