Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurant Chimney Graft Technique | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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. | Index procedure and through 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 safety endpoints |
Not provided
Inclusion Criteria:
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:
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
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordensklinikum Linz GmbH / Elisabethinen | Linz | 4010 | Austria | |||
| CHU de Bordeaux - Centre Universitaire Pellegrin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| through 30 days and annually up to 5 year follow up |
| Secondary imaging based endpoints |
| 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 | at 30 days and at annual follow-up until 60 months post-index procedure |
| Bordeaux |
| 33000 |
| France |
| Hôpitaux Universitaires Paris Ile-de-France Ouest - Hôpital Ambroise-Paré | Boulogne-Billancourt | 92104 | France |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| Elisabeth Krankenhaus Essen GmbH | Essen | 45138 | Germany |
| Universitäts Klinikum Frankfurt - Goethe-Universität | Frankfurt am Main | 60590 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| St. Franziskus-Hospital Münster GmbH | Münster | 48145 | Germany |
| Evaggelismos General Hospital of Athens | Athens | 106 76 | Greece |
| University Hospital of Larissa | Larissa | 413 34 | Greece |
| Ippokrateio General Hospital of Thessaloniki | Thessaloniki | 546 42 | Greece |
| Azienda Ospedaliera di Cosenza | Cosenza | 87100 | Italy |
| Ospedale Civile Sant'Andrea | La Spezia | 19124 | Italy |
| Azienda Ospedaliera San Camillo Forlanini - Ospedale San Camillo | Roma | 00152 | Italy |
| Stichting Rijnstate Ziekenhuis | Arnhem | 6815 | Netherlands |
| Medisch Spectrum Twente | Enschede | 7512 KZ | Netherlands |
| Zuyderland Medisch Centrum | Heerlen | 6419PC | Netherlands |
| Hospital de Santa Marta | Lisbon | 1169-024 | Portugal |
| Russian Cardiologic Research and Production Complex, Russian Ministry of Health | Moscow | 121552 | Russia |
| CINRE s.r.o. | Bratislava | 85105 | Slovakia |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Corporacío Parc Taulí - Hospital de Sabadell | Sabadell | 08208 | Spain |
| Skånes Universitetssjukhus Malmö | Malmö | 205 02 | Sweden |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | 1011 | Switzerland |
| St George's University Hospitals - NHS Trust | London | SW17 0QT | United Kingdom |
| Central Manchester University Hospitals NHS - Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided