Endurant CHevAr New Indication Trial: ENCHANT

NCT03320252 | Active Not Recruiting

• 1 other identifier: MDT16022
• Study Type: observational
• Target: 150
• Locations: 13 countries
• Sites: 26

Brief Summary

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

Conditions

AAA - Abdominal Aortic Aneurysm

Keywords

CHEVAR; Chimney; Juxtarenal; Short Infrarenal /neck; Endurant

Outcome Measures

Primary Outcomes (2)

• Primary safety endpoint evaluated by proportion of subjects experiencing a Major Adverse Event through 30 days post-index procedure

  Major Adverse Events include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke

  through 30 days post-index procedure

• The primary performance endpoint is defined as the proportion of subjects who have technical success at the time of the index procedure and are free from secondary interventions through 365 days.

  Index procedure and through 365 days

Secondary Outcomes (4)

• Clinical Succes

  Index procedure and within 30-days post-index procedure

• Secondary safety endpoints

  through 30 days and annually up to 5 year follow up

• Secondary imaging based endpoints

  at 30 days and at annual follow-up until 60 months post-index procedure

• Change in renal function

  at 30 days and at annual follow-up until 60 months post-index procedure

Interventions

Endurant Chimney Graft Technique DEVICE

Medtronic Endurant II and Endurant IIs Stent Graft Systems and balloon-expandable covered stent graft systems approved for use in the renal arteries. These devices will be utilized in a chimney graft configuration.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be comprised of subjects that meet the indications for the Endurant Chimney Graft Technique for the endovascular treatment of juxtarenal aortic aneurysms with a short infrarenal neck.

You may qualify if:

• Subject is ≥18 years old
• Subject is scheduled for primary treatment of the juxtarenal aortic aneurysm with a short infrarenal neck (i.e. no revision subjects)
• Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
• Subject has provided written informed consent
• Subject is an eligible candidate according to the currently available Endurant II/IIs instructions for use for ChEVAR
• Subject has a juxtarenal aortic aneurysm with a short infrarenal neck (definition of juxtarenal aortic aneurysm with a short infrarenal neck will be in accordance with commercially available Endurant II/IIs instructions for use for ChEVAR).

You may not qualify if:

• Subject is participating in a concurrent study which may confound study results
• Subject has a life expectancy ≤ 2 year
• Subject has an aneurysm that is:
• Suprarenal or pararenal
• Isolated iliofemoral
• Mycotic
• Inflammatory
• Pseudoaneurysm
• Subject requires emergent aneurysm treatment, for example, trauma or rupture
• Subject has previously undergone surgical treatment for abdominal aortic aneurysm
• Subject is a female of childbearing potential in whom pregnancy cannot be excluded
• Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
• Subject has a creatinine level \>2.0 mg/dl (or \>176.8 μmol/L) and/or is on dialysis
• Subject has an active COVID-19 infection or relevant history of COVID-19. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 6 months prior to enrollment

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (26)

Ordensklinikum Linz GmbH / Elisabethinen

Linz, 4010, Austria

Location

CHU de Bordeaux - Centre Universitaire Pellegrin

Bordeaux, 33000, France

Location

Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré

Boulogne-Billancourt, 92104, France

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Elisabeth Krankenhaus Essen GmbH

Essen, 45138, Germany

Location

Universitäts Klinikum Frankfurt - Goethe-Universität

Frankfurt am Main, 60590, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

St. Franziskus-Hospital Münster GmbH

Münster, 48145, Germany

Location

Evaggelismos General Hospital of Athens

Athens, 106 76, Greece

Location

University Hospital of Larissa

Larissa, 413 34, Greece

Location

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, 546 42, Greece

Location

Azienda Ospedaliera di Cosenza

Cosenza, 87100, Italy

Location

Ospedale Civile Sant'Andrea

La Spezia, 19124, Italy

Location

Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo

Roma, 00152, Italy

Location

Stichting Rijnstate Ziekenhuis

Arnhem, 6815, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7512 KZ, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, 6419PC, Netherlands

Location

Hospital de Santa Marta

Lisbon, 1169-024, Portugal

Location

Russian Cardiologic Research and Production Complex, Russian Ministry of Health

Moscow, 121552, Russia

Location

CINRE s.r.o.

Bratislava, 85105, Slovakia

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Corporacío Parc Taulí - Hospital de Sabadell

Sabadell, 08208, Spain

Location

Skånes Universitetssjukhus Malmö

Malmo, 205 02, Sweden

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

St George's University Hospitals - NHS Trust

London, SW17 0QT, United Kingdom

Location

Central Manchester University Hospitals NHS - Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 25, 2017
• Study Start: October 26, 2017
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); ES (2); FR (2); RU (1); PT (1); NL (3); DE (5); GR (3); AU (1); SL (1); CH (1); SE (1); GB (2)