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

NCT02480595 | Suspended DMC

• 1 other identifier: ARCHYTAS
• Study Type: observational
• Target: 500
• Locations: 6 countries
• Sites: 37

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.

Conditions

Abdominal Aortic Aneurysms

Keywords

Abdominal Aortic Aneurysm; AAA; Endovascular; EVAR; Stent; Stent Graft; High Angle; Tortuous

Outcome Measures

Primary Outcomes (1)

• Treatment Success

  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 Outcomes (1)

• Graft Performance

  30 Days to 12 Months

Study Arms (1)

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

Interventions

Stent Graft DEVICE

Endovascular repair of abdominal aortic aneurysm (EVAR)

Also known as: Aorfix™ stent, Aorfix™ stent graft

EVAR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
• Intention to electively implant the Aorfix™ Stent Graft System.

You may not qualify if:

• Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU).
• Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site.
• Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure.
• 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.

Sponsors & Collaborators

• Lombard Medical: lead

Study Sites (37)

Prague University Hospital

Prague, 12808, Czechia

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Herzzentrum Köln

Cologne, 50924, Germany

Location

Alfried Krupp Krankenhaus

Essen, 45131, Germany

Location

Elisabeth-Krankenhaus Essen

Essen, 45134, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

University Hospital Halle

Halle, 06120, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

St.Vincenz-Krankenhaus Limburg

Limburg, 65549, Germany

Location

Bonifatius Hospital

Lingen, 49808, Germany

Location

Klinikum Rechts der Isar der TU München

München, 81675, Germany

Location

Ammerland Klinik GmbH

Westerstede, 26655, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Ospedale Papa Giovanni 23

Bergamo, 21100, Italy

Location

Sant'Anna

Como, 22020, Italy

Location

Ospeale Maggiore

Lodi, 26900, Italy

Location

Ospedale Sant'Andrea delle Fratte

Perugia, 06100, Italy

Location

Tor Vergata

Rome, Italy

Location

Policlinico San Donato IRCCS

San Donato, 20097, Italy

Location

Auckland Hospital

Auckland, 1023, New Zealand

Location

University Clinic

Barcelona, 8036, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

H. Universitari Dr. Josep Trueta

Girona, 17007, Spain

Location

University Hospital S. Cecilio

Granada, 18012, Spain

Location

HGU Gregorio Marañon

Madrid, 28007, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

Location

H. Universitari Son Espases

Palma de Mallorca, 07120, Spain

Location

Hospital Universitario Donostia

San Sebastián, 20014, Spain

Location

H. Marqués de Valdecilla

Santander, 39008, Spain

Location

Royal Bournemouth General Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Mid Essex Hospital - Broomfield

Chelmsford, CM1 7ET, United Kingdom

Location

Northwick Park Hospital

Harrow, HA1 3UJ, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

Nottingham University Hospital

Nottingham, NG7 2UH, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

Related Links

• Lombard Medical Home Page

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Vicente Riambau

  University Clinic, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 24, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); CZ (1); IT (6); ES (9); DE (12); GB (8)