Endurant CHevAr New Indication Trial: ENCHANT

AAA - Abdominal Aortic Aneurysm Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03320252
• Other study ID #: MDT16022
• Status: Recruiting
• Start date: October 26, 2017
• Est. completion date: November 2029

Study information

• Verified date: February 2024
• Source: Medtronic Cardiovascular
• Contact: Indir Sertovic
• Phone: +31611252650
• Email: indir.sertovic2[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2029
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AAA - Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Endurant Chimney Graft Technique
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.

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz GmbH / Elisabethinen	Linz
France	CHU de Bordeaux - Centre Universitaire Pellegrin	Bordeaux
France	Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré	Boulogne Billancourt
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Elisabeth Krankenhaus Essen GmbH	Essen
Germany	Universitäts Klinikum Frankfurt - Goethe-Universität	Frankfurt am Main
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Krankenhaus Porz am Rhein gGmbH	Köln
Germany	St. Franziskus-Hospital Münster GmbH	Münster
Greece	Evaggelismos General Hospital of Athens	Athens
Greece	University Hospital of Larissa	Larissa
Greece	Ippokrateio General Hospital of Thessaloniki	Thessaloniki
Ireland	Galway University Hospitals - University Hospital Galway (UHG)	Galway
Italy	Azienda Ospedaliera di Cosenza	Cosenza
Italy	Ospedale Civile Sant'Andrea	La Spezia
Italy	Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo	Roma
Netherlands	Stichting Rijnstate Ziekenhuis	Arnhem
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Zuyderland Medisch Centrum	Heerlen
Portugal	Hospital de Santa Marta	Lisboa
Russian Federation	Russian Cardiologic Research and Production Complex, Russian Ministry of Health	Moscow
Slovakia	CINRE s.r.o.	Bratislava
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Corporacío Parc Taulí - Hospital de Sabadell	Sabadell
Sweden	Skånes Universitetssjukhus Malmö	Malmö
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne
Switzerland	UniversitätsSpital Zürich	Zürich
United Kingdom	St George's University Hospitals - NHS Trust	London
United Kingdom	Central Manchester University Hospitals NHS - Manchester Royal Infirmary	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

Austria,  France,  Germany,  Greece,  Ireland,  Italy,  Netherlands,  Portugal,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	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	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
Secondary	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