AAA, AAA - Abdominal Aortic Aneurysm
Conditions
Keywords
randomized
Brief summary
Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).
Interventions
Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
FDA approved comparator of choice
Sponsors
Endologix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult age 21 and older * Subjects with minimum of 2 year life expectancy * Subjects have signed the informed consent document * Subjects with unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices. * Patient must be able and willing to comply with all required follow-up exams.
Exclusion criteria
* Currently participating in another trial where the primary endpoint has not been reached yet. * Known allergy to any of the device components * Pregnant (females of childbearing potential only) * Known connective tissue disorders * Known active infection * Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR. * Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Dilation in mm | Through 5 years | — |
| Number of Participants with Freedom from Aneurysm-Related Complications (ARC) | Through 5 years | Composite endpoint consisting of aneurysm-related death, aneurysm rupture, conversion to open surgery, type I and III endoleaks, device migration (\>10mm), aneurysm sac enlargement (\>5mm), occlusion, and freedom from device-related interventions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Secondary interventions | At 30 days, 12 months, and annually up to five years | — |
| Count of participants with aneurysm sac enlargement (>5mm) | 12 months, and annually up to five years | — |
| Count of subjects with occlusion | 30 days, 12 months, and annually up to five years | — |
| Number of Participants with Freedom From device-related interventions | 30 days, 12 months, and annually up to five years | — |
| Count of subjects lacking device integrity | At 30 days, 12 months, and annually up to five years | device patency (stenosis and occlusion) and integrity (kinking, fracture, and polymer leak) |
| count of aneurysm ruptures | At 30 days, 12 months, and annually up to five years | — |
| Count of participants with conversion to open surgery | At 30 days, 12 months, and annually up to five years | — |
| Count of participants with type I and III endoleaks | At 30 days, 12 months, and annually up to five years | — |
| Count of participants with device migration (>10mm) | 12 months, and annually up to five years | — |
| Number of Major Adverse Events (MAEs) | At 30 days and 12 months | All-cause mortality, Bowel ischemia, Myocardial infarction, Paraplegia, Renal Failure, Respiratory Failure, Stroke, Index Procedural Blood Loss ≥ 1000mL |
| Count of participants All Cause Mortality | At 30 days, 12 months, and annually up to five years | — |
| Count of participants AAA-related Mortality | At 30 days, 12 months, and annually up to five years | — |
| Number of Type Ia endoleaks | At 30 days, 12 months, and annually up to five years | — |
| Number of Type Ib | At 30 days, 12 months, and annually up to five years | — |
| Number of Type II | At 30 days, 12 months, and annually up to five years | — |
| Number of Type IV | At 30 days, 12 months, and annually up to five years | — |
| Number of Type III | At 30 days, 12 months, and annually up to five years | — |
| Number of Unknown Enooleaks | At 30 days, 12 months, and annually up to five years | — |
Countries
United States
Contacts
CONTACTNoel DeSisto
CONTACTSanjana Tabassum
PRINCIPAL_INVESTIGATORSean Lyden, MD
The Cleveland Clinic
PRINCIPAL_INVESTIGATORChristopher Kwolek, MD
Newton-Wellesley Hospital
PRINCIPAL_INVESTIGATORHence Verhagen, MD, PhD
Erasmus University Study Center
Outcome results
None listed