AAA-SHAPE Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Official Title
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Purpose
The purpose of this research is to determine if the IMPEDE-FX RapidFill System is safe and helps to shrink abdominal aortic aneurysm (AAA - a bulge or swelling due to weakening of the walls of the aorta, which is the main blood vessel that carries blood from your heart to other parts of your body) sacs after an endovascular stent graft (a fabric tube supported by metal wire stents that reinforces a weakened aorta) has been placed. The IMPEDE-FX RapidFill System used in this study is classified as investigational, which means it has not been approved by the Food and Drug Administration (FDA).
Could this study be right for you?
Inclusion:
- A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥ 5.0 cm in women
- Thrombus burden (percentage of the AAA sac occupied by thrombus) <50%, based on pre-procedure CTA
- Maximum Lumen diameter within the AAA sac of ≥40mm
- The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200
Exclusion:
- An inability to provide informed consent
- Enrolled in another clinical study that could interfere with the outcomes being studied in this trial
- Unable or unwilling to comply with study follow-up requirements
Inclusion and Exclusion Criteria varies, please contact Study Coordinator for more information.