Clinical trial NCT03320252: Endurant CHevAr New Indication Trial: ENCHANT
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: AAA - Abdominal Aortic Aneurysm
Keywords: CHEVAR
Chimney
Juxtarenal
Short Infrarenal /neck
Endurant
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary safety endpoint evaluated by proportion of subjects experiencing a Major Adverse Event through 30 days post-index procedure
timeFrame: through 30 days post-index procedure
measure: 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.
timeFrame: Index procedure and through 365 days
Secondary outcomes:
measure: Clinical Succes
timeFrame: Index procedure and within 30-days post-index procedure
measure: Secondary safety endpoints
timeFrame: through 30 days and annually up to 5 year follow up
measure: Secondary imaging based endpoints
timeFrame: at 30 days and at annual follow-up until 60 months post-index procedure
measure: Change in renal function
timeFrame: at 30 days and at annual follow-up until 60 months post-index procedure
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH / Elisabethinen
city: Bordeaux
country: France
facility: CHU de Bordeaux - Centre Universitaire Pellegrin
city: Boulogne Billancourt
country: France
facility: Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen GmbH
city: Frankfurt am Main
country: Germany
facility: Universitäts Klinikum Frankfurt - Goethe-Universität
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Münster
country: Germany
facility: St. Franziskus-Hospital Münster GmbH
city: Athens
country: Greece
facility: Evaggelismos General Hospital of Athens
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Ippokrateio General Hospital of Thessaloniki
city: Cosenza
country: Italy
facility: Azienda Ospedaliera di Cosenza
city: La Spezia
country: Italy
facility: Ospedale Civile Sant'Andrea
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo
city: Arnhem
country: Netherlands
facility: Stichting Rijnstate Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta
city: Moscow
country: Russian Federation
facility: Russian Cardiologic Research and Production Complex, Russian Ministry of Health
city: Bratislava
country: Slovakia
facility: CINRE s.r.o.
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Sabadell
country: Spain
facility: Corporacío Parc Taulí - Hospital de Sabadell
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus Malmö
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: London
country: United Kingdom
facility: St George's University Hospitals - NHS Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary
Study officials:
References: