AAA - Abdominal Aortic AneurysmENCHANTNCT03320252
Endurant CHevAr New Indication Trial: ENCHANT
An observational study of AAA - Abdominal Aortic Aneurysm, run by Medtronic Cardiovascular at 26 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AAA - Abdominal Aortic Aneurysm
- What is being tested?
- Endurant Chimney Graft Technique
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 26 sitesin 13 countries
- Study dates
- 26 Oct 2017to Jul 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
26 sites in 13 countries.
26 sites in 13 countries
Germany5 sites
Klinikum Chemnitz gGmbH
Chemnitz, 09116
Elisabeth Krankenhaus Essen GmbH
Essen, 45138
Universitäts Klinikum Frankfurt - Goethe-Universität
Frankfurt am Main, 60590
Universitätsklinikum Heidelberg
Heidelberg, 69120
St. Franziskus-Hospital Münster GmbH
Münster, 48145
Greece3 sites
Evaggelismos General Hospital of Athens
Athens, 106 76
University Hospital of Larissa
Larissa, 413 34
Ippokrateio General Hospital of Thessaloniki
Thessaloniki, 546 42
Italy3 sites
Azienda Ospedaliera di Cosenza
Cosenza, 87100
Ospedale Civile Sant'Andrea
La Spezia, 19124
Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo
Roma, 00152
Netherlands3 sites
Stichting Rijnstate Ziekenhuis
Arnhem, 6815
Medisch Spectrum Twente
Enschede, 7512 KZ
Zuyderland Medisch Centrum
Heerlen, 6419PC
France2 sites
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux, 33000
Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
Boulogne-Billancourt, 92104
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Corporacío Parc Taulí - Hospital de Sabadell
Sabadell, 08208
United Kingdom2 sites
St George's University Hospitals - NHS Trust
London, SW17 0QT
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
Manchester, M13 9WL
Russia1 site
Russian Cardiologic Research and Production Complex, Russian Ministry of Health
Moscow, 121552
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
About this study
Official title: 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.
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Being tested
- Endurant Chimney Graft Technique
- Keywords
- CHEVAR, Chimney, Juxtarenal, Short Infrarenal /neck, Endurant
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurant Chimney Graft TechniqueDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Index procedure and through 365 days
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: at 30 days and at annual follow-up until 60 months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start26 Oct 2017
- Primary completion22 Apr 2026
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AAA - Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320252
- Sponsor's protocol ID
- MDT16022
- Acronym
- ENCHANT
- Status last verified
- May 2026
- First submitted
- 21 Sep 2017
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No