AAA - Abdominal Aortic Aneurysm
Conditions
Keywords
CHEVAR, Chimney, Juxtarenal, Short Infrarenal /neck, Endurant
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.
Interventions
DEVICEEndurant 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.
Sponsors
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Succes | Index procedure and within 30-days post-index procedure | 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 |
| Secondary safety endpoints | through 30 days and annually up to 5 year follow up | * Aneurysm rupture * Conversion to open surgery * Aneurysm related mortality * All-cause mortality * MAEs through 365 days |
| Secondary imaging based endpoints | at 30 days and at annual follow-up until 60 months post-index procedure | * 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 |
| Change in renal function | at 30 days and at annual follow-up until 60 months post-index procedure | Change in renal function compared to baseline |
Countries
Austria, France, Germany, Greece, Italy, Netherlands, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed