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Treatment for abdominal aortic aneurysm using IMPEDE-FX RapidFill

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Not applicable Interventional Shape Memory Medical, Inc. · NCT06029660

This study is testing if using IMPEDE-FX RapidFill implants along with standard surgery can help people with abdominal aortic aneurysms shrink their aneurysm sacs and improve their health.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorShape Memory Medical, Inc. Industry-sponsored
Locations49 sites (Birmingham, Alabama and 48 other locations)
Trial IDNCT06029660 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of IMPEDE-FX RapidFill implants in promoting shrinkage of abdominal aortic aneurysm (AAA) sacs when used alongside standard endovascular aneurysm repair (EVAR) procedures. Participants will be individuals who are candidates for elective EVAR and have specific anatomical criteria. The study will assess the percentage of subjects experiencing aneurysm sac shrinkage post-treatment, contributing to improved patient outcomes in managing AAA.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for elective EVAR of an infrarenal fusiform aortic aneurysm measuring 5.5 cm or larger in men and 5.0 cm or larger in women.

Not a fit: Patients with ruptured or infected aneurysms, or those with vascular anatomy that complicates safe catheter access, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to better management of abdominal aortic aneurysms, potentially reducing the need for more invasive procedures.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using adjunct therapies for aneurysm management, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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.

Exclusion Criteria:

General

1. An inability to provide informed consent.
2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
3. Unable or unwilling to comply with study follow-up requirements.
4. Prisoner or member of other vulnerable population

Anatomical

1. Concomitant iliac artery ectasia or aneurysm
2. Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
4. Connective tissue disorder (e.g., Marfan's syndrome)
5. Aneurysmal disease of the descending thoracic aorta
6. Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties

EVAR/Procedural

1. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA
2. Use of an aortic stent graft other than those specified1 for a particular site
3. Planned use of the chosen stent graft outside its instructions for use (IFU)
4. Use of fenestrated stent grafts or chimney techniques
5. Use of the Heli-FX EndoAnchor system
6. Use of embolic devices other than the investigational product to embolize the AAA sac
7. Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries
8. Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries

Medical History/Conditions

1. Coagulopathy or uncontrolled bleeding disorder
2. Serum creatinine level \>2.5 mg/dL
3. Cerebrovascular accident within 3 months prior to the procedure
4. Myocardial infarction and/or major heart surgery within 3 months prior to the procedure
5. Atrial fibrillation that is not well rate controlled
6. Life expectancy of \<2 years post-procedure
7. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.
8. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC \>11,000/mm3)
9. A condition that inhibits radiographic visualization during the implantation procedure
10. History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason.
11. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial
12. Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial

Where this trial is running

Birmingham, Alabama and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Aortic Aneurysm, AbdominalAbdominal Aortic Aneurysm
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.