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

Not Applicable

Recruiting

• Conditions: Aortic Aneurysm, Abdominal
• Interventions: Device: IMPEDE-FX RapidFill Implants; Procedure: EndoVascular Aneurysm Repair

• Registration Number: NCT06029660
• Lead Sponsor: Shape Memory Medical, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Study Start: 2024-04-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Primary Completion: 2027-06
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	IMPEDE-FX RapidFill Implants	Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
Treatment	EndoVascular Aneurysm Repair	Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
Control	EndoVascular Aneurysm Repair	Control Arm: Subjects in the control arm will only have an EVAR device implanted.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days	30 days	Freedom from the following through 30 days post-index procedure: * Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss \>1000 mL.; * AAA-rupture or AAA-perforation; * Conversion to Open Repair
Primary Effectiveness Endpoint : AAA Sac Regression at 1 year	1 year	The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.

Trial Locations

Locations (35)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Honor Health; 🇺🇸 Scottsdale, Arizona, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

USC Keck; 🇺🇸 Los Angeles, California, United States

Delray Medical Center; 🇺🇸 Delray Beach, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Maine Medical; 🇺🇸 Portland, Maine, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Buffalo VA Western New York; 🇺🇸 Buffalo, New York, United States

NYU Langone; 🇺🇸 New York, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

TriHealth Heart Institute; 🇺🇸 Cincinnati, Ohio, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Corewell Health; 🇺🇸 Grand Rapids, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

The Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Sanford Health; 🇺🇸 Sioux Falls, South Dakota, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Baylor Scott and White; 🇺🇸 Plano, Texas, United States

Inova Schar Heart and Vascular; 🇺🇸 Falls Church, Virginia, United States

Sentara Norfolk General; 🇺🇸 Norfolk, Virginia, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Marie Lannelongue Hospital; 🇫🇷 Paris, Le Plessis-Robinson, France

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

ETZ Elisabeth; 🇳🇱 Tilburg, Netherlands

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

St Georges University Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom