Endurant CHevAr New Indication Trial: ENCHANT
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Primary safety endpoint evaluated by proportion of subjects experiencing a Major Adverse Event through 30 days post-index procedure — 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 - 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
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Ordensklinikum Linz GmbH / Elisabethinen | 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 | |
| Ippokrateio General Hospital of Thessaloniki | Thessaloniki | Greece | |
| Azienda Ospedaliera di Cosenza | Cosenza | Italy | |
| Ospedale Civile Sant'Andrea | La Spezia | Italy | |
| Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo | Roma | Italy | |
| Stichting Rijnstate Ziekenhuis | Arnhem | Netherlands | |
| Medisch Spectrum Twente | Enschede | Netherlands | |
| Zuyderland Medisch Centrum | Heerlen | Netherlands | |
| Hospital de Santa Marta | Lisbon | Portugal | |
| Russian Cardiologic Research and Production Complex, Russian Ministry of Health | Moscow | Russia | |
| CINRE s.r.o. | Bratislava | Slovakia | |
| Hospital Clinic de Barcelona | Barcelona | Spain | |
| Corporacío Parc Taulí - Hospital de Sabadell | Sabadell | Spain | |
| Skånes Universitetssjukhus Malmö | Malmö | Sweden | |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Switzerland | |
| St George's University Hospitals - NHS Trust | London | United Kingdom | |
| Central Manchester University Hospitals NHS - Manchester Royal Infirmary | Manchester | United Kingdom |
More Medtronic Cardiovascular trials in Sweden
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03320252 on ClinicalTrials.gov ↗ ← All trials in Sweden