AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
R
Raghu Motaganahalli, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
2 participants needed
1 Location
Brief description of study
Why is this study being done?
To determine the safety and effectiveness of IMPEDE-FX RapidFill to improve AAA sac behavior when used with EVAR stent graft treatment.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
What will happen during the study?
- Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
- Control Arm: Subjects in the control arm will only have an EVAR device implanted.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Abdominal Aortic Aneurysm
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- ≥18 years of age
- 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 Criteria:
- 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.
- Prisoner or member of other vulnerable population
Updated on
21 Apr 2025.
Study ID: SURG-SMM-AAA-SHAPE, 21455
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
