Endurant CHevAr New Indication Trial: ENCHANT (ENCHANT)

Endurant CHevAr New Indication Trial: ENCHANT - Post-market Study of the Endurant CHEVAR Technique for the Treatment of Juxtarenal Aortic Aneurysms With a Short Infrarenal Neck

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.

Study Overview

• Status: Active, not recruiting
• Conditions: AAA - Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Endurant Chimney Graft Technique

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4010
    • Ordensklinikum Linz GmbH / Elisabethinen
• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux - Centre Universitaire Pellegrin
  • Boulogne-Billancourt, France, 92104
    • Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
• Germany
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH
  • Essen, Germany, 45138
    • Elisabeth Krankenhaus Essen GmbH
  • Frankfurt am Main, Germany, 60590
    • Universitäts Klinikum Frankfurt - Goethe-Universität
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Münster, Germany, 48145
    • St. Franziskus-Hospital Münster GmbH
• Greece
  • Athens, Greece, 106 76
    • Evaggelismos General Hospital of Athens
  • Larissa, Greece, 413 34
    • University Hospital of Larissa
  • Thessaloniki, Greece, 546 42
    • Ippokrateio General Hospital of Thessaloniki
• Italy
  • Cosenza, Italy, 87100
    • Azienda Ospedaliera di Cosenza
  • La Spezia, Italy, 19124
    • Ospedale Civile Sant'Andrea
  • Roma, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo
• Netherlands
  • Arnhem, Netherlands, 6815
    • Stichting Rijnstate Ziekenhuis
  • Enschede, Netherlands, 7512 KZ
    • Medisch Spectrum Twente
  • Heerlen, Netherlands, 6419PC
    • Zuyderland Medisch Centrum
• Portugal
  • Lisbon, Portugal, 1169-024
    • Hospital de Santa Marta
• Russia
  • Moscow, Russia, 121552
    • Russian Cardiologic Research and Production Complex, Russian Ministry of Health
• Slovakia
  • Bratislava, Slovakia, 85105
    • CINRE s.r.o.
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Sabadell, Spain, 08208
    • Corporacío Parc Taulí - Hospital de Sabadell
• Sweden
  • Malmö, Sweden, 205 02
    • Skånes Universitetssjukhus Malmö
• Switzerland
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois (CHUV)
• United Kingdom
  • London, United Kingdom, SW17 0QT
    • St George's University Hospitals - NHS Trust
  • Manchester, United Kingdom, M13 9WL
    • Central Manchester University Hospitals NHS - Manchester Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Succes	Technical success and freedom from intra-operative death and freedom from type Ia/III endoleak in the first image within 30-days post-index procedure	Index procedure and within 30-days post-index procedure
Secondary safety endpoints	Aneurysm rupture; Conversion to open surgery; Aneurysm related mortality; All-cause mortality; MAEs through 365 days	through 30 days and annually up to 5 year follow up
Secondary imaging based endpoints	Stent graft fractures (endograft, chimney graft); Stent graft occlusion (endograft, chimney graft); Endoleak of all types; Stent graft migration >10 mm (endograft); Aneurysm sac expansion ≥ 5 mm	at 30 days and at annual follow-up until 60 months post-index procedure
Change in renal function	Change in renal function compared to baseline	at 30 days and at annual follow-up until 60 months post-index procedure

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): April 22, 2026
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Juxtarenal; CHEVAR; Chimney; Short Infrarenal /neck; Endurant
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: MDT16022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No