Abdominal aortic aneurysms Circulatory System Abdominal aortic aneurysms
Conditions
Interventions
Participants are identified as eligible for the study by their clinical team if they have planned for treatment with the Altura stent graft system. Patients are provided with a patient information she
Sponsors
Lombard Medical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient being implanted with an Altura stent graft 2. Male or female at least 60 years’ old 3. Subject has signed informed consent for data and image release 4. Subjects with abdominal aortic aneurysm and eligible for endovascular repair
Exclusion criteria
Exclusion criteria: 1. Currently participating in another related study where primary endpoint has not been reached yet 2. Mycotic or infected aneurysms 3. Aneurysms associated with a known connective tissue disorder 4. Occluded iliac access vessels 5. Ruptured abdominal aortic aneurysm 6. Patients deemed by the investigator to lie outside the Instructions for Use of the Altura®-System 7. Life expectancy less than 2 years 8. Known allergy to any of the device components 9. Pregnancy or breastfeeding or any plan to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Procedural technical success is measured using the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investigator) at 30 days 2. Freedom from endoleak of any type, apart from type 2 over 5 years is measured using the the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investigator) at 1, 2, 3, 4 and 5 years 3. Assessment Peri-operative Safety Parameters is measured using the the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investigator) at 30 days post-procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Freedom from conversion to open surgical repair through to five years is measured using the patient notes at 30 days and then annually to 5 years 2. Freedom from aneurysm rupture is measured using the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investigator) at 30 days, and 1, 2, 3, 4, and 5 years 3. Clinically significant migration, requiring intervention or an increased frequency of surveillance through to five years is measured using the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investigator) at 30 days, and 1, 2, 3, 4, and 5 years 4. Aneurysm enlargement (>5mm) through to five years is measured using the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investigator) at 30 days, and 1, 2, 3, 4, and 5 years 5. Aneurysm regression (>5mm) through to five years is measured using the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investigator) at 30 days, and 1, 2, 3, 4, and 5 years 6. Secondary endovascular procedures of any type through to five years is measured using the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investigator) at 30 days, and 1, 2, 3, 4, and 5 years 7. Secondary vascular and/or endovascular procedures for resolution of: 7.1. Endoleak of any type is measured using the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investigator) at 30 days, and 1, 2, 3, 4, and 5 years 7.2. Device occlusion (due to thrombus or other causes) is measured using the patient notes and imaging records (either CT scan, or ultrasound +/- abdominal x-ray, as determined by the investiga | — |
Countries
United Kingdom
Contacts
Public ContactNatalie Hayes
Outcome results
None listed