Abdominal aortic aneurysm or aortic dilatation. in layman terms
Conditions
Interventions
Endovascular repair of an abdominal aortic aneurysm is an minimally
interventional procedure that will allow aneurysm exclusion using a stent graft
passed inside the aorta either percutaneously or f
Sponsors
Anson Medical Ltd.; t/a Lombard Medical Cardiovascular Devices Division
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of abdominal aortic aneurysm 50 mm or larger in diameter, 40 mm or larger in diameter if symptomatic (i.e. pain, embolisation), or documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery(ies), or any saccular aneurysm. 2. Infrarenal neck with a minimum length of 15 mm and a neck angulation between 60° and 90°, as assessed in 3 dimensions. 3. The iliac artery diameter must be of appropriate diameter (1 mm smaller than the device diameter), with an appropriate distal landing length. The tortuosity of the common or external iliac arteries or femoral arteries must be low to medium (refer to operations manual). 4. Patient provides written informed consent. 5. Patients >18 years who are suitable for endovascular repair. 6. Patient fit for endovascular surgery, with a diameter at the access sites of 7mm or larger bilaterally. 7. Patient has a life expectancy longer than the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Patient has a ruptured aneurysm. 2. Patient has insufficient length of proximal aneurysm neck (2mg/dL or >176 mmol/l). 14. Patient has connective tissue disease (e.g. Marfan syndrome, Ehlers-Danlos syndrome). 15. Patient has a bleeding diathesis or dyscrasia. 16. Patient is not willing to comply with the follow up sequence, or his geographic location does not allow appropriate follow up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are acute technical success, initial performance and safety at 1-month follow up. Technical success is defined as successful passage of delivery system to the landing zone accurate placement of the device at the target zone, accurate positioning of the contra-lateral limb and withdrawal of the delivery system post deployment. Performance is defined as aneurysmal exclusion and flow restoration as evidenced by freedom from acute endoleak. Safety is defined as the absence of clinical complications during and after the clinical procedure (up top 1-month post-procedure). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will examine recovery factors: operative time, ICU duration, blood loss, days to normal diet, days to discharge, days to ambulation, freedom from non-clinical events, need for secondary procedure and conversion to uni-iliac. Also safety at 6-month follow-up as measured by serious adverse events that occur up to 6-months post-procedure. | — |
Countries
Netherlands
Outcome results
None listed