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 Type
OBSERVATIONAL
Enrollment
150
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.
Ordensklinikum Linz GmbH / Elisabethinen
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
Time frame: 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.
Time frame: Index procedure and through 365 days
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 30 days and at annual follow-up until 60 months post-index procedure
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Linz, Austria
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux, France
Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré
Boulogne-Billancourt, France
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Elisabeth Krankenhaus Essen GmbH
Essen, Germany
Universitäts Klinikum Frankfurt - Goethe-Universität
Frankfurt am Main, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
St. Franziskus-Hospital Münster GmbH
Münster, Germany
Evaggelismos General Hospital of Athens
Athens, Greece
University Hospital of Larissa
Larissa, Greece
...and 16 more locations