Altura post-market registry study: Altitude
- Conditions
- Circulatory SystemAbdominal aortic aneurysms
- Registration Number
- ISRCTN13771116
- Lead Sponsor
- ombard Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1200
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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<br> 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<br> 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<br>
- Secondary Outcome Measures
Name Time Method