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?
  1. Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
  2. 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
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only