Clinical trial NCT06029660: AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Official title: AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: Abdominal Aortic Aneurysm
Lead sponsor: Shape Memory Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2023-09-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, multicenter, randomized, open-label trial.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
timeFrame: 1 year
measure: Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Los Angeles
country: United States
facility: USC Keck
state: California
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Portland
country: United States
facility: Maine Medical
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Buffalo
country: United States
facility: Buffalo VA Western New York
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: TriHealth Heart Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Plano
country: United States
facility: Baylor Scott and White
state: Texas
city: Falls Church
country: United States
facility: Inova Schar Heart and Vascular
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Paris
country: France
facility: Marie Lannelongue Hospital
state: Le Plessis-Robinson
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: London
country: United Kingdom
facility: St Georges University Hospitals NHS Foundation Trust
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Marc Schermerhorn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: