AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
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Clinical Trial Information
Trial Contact: Ngo, George M.; Cox, Caitlin L; Harms, Gabrielle T; Rodriguez, Adriana C
Trial Phone: 3218439657 ; 321-841-1505 ; 4077012135 ; 321.843.1838
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IRB No: W23.243.11
Protocol Abbrev: AAA-SHAPE
Principal Investigator: Aleem Mirza, MD
Phase: Device: Significant Risk
Age Group: Adult
Secondary Protocol No: CRD 1029- Version 1.1
Treatment: The IMPEDE-FX RapidFill System is intended to be used with commercially available endovascular grafts in the treatment of patients meeting the minimum anatomical criteria, with infrarenal abdominal aortic aneurysms (AAAs). Once the endovascular aneurysm repair (EVAR) the procedure is complete, the IMPEDE-FX RapidFill System is used to fill the aneurysm sac with IMPEDE-FX RapidFill Implants to promote aneurysm sac shrinkage.
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT06029660
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Objective
To determine the safety and effectiveness of IMPEDE-FX RapidFill to
increase the percentage of subjects with shrinkage of the abdominal aortic
aneurysm sac when used as an adjunct to on-label endovascular aneurysm
repair (EVAR) stent graft treatment in trial subjects considered candidates
for elective EVAR -
Key Eligibility
1. ≥18 years of age
2. A candidate for elective EVAR of an infrarenal fusiform aortic
aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;
3. Thrombus burden (percentage of the AAA sac occupied by
thrombus) <50%, based on pre-procedure CTA
4. Maximum Lumen diameter within the AAA sac of ≥40mm.
5. The predicted minimum number of IMPEDE-FX RapidFill Implants
for the subject is ≤200
