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

Primary Purpose

Aortic Aneurysm, Abdominal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IMPEDE-FX RapidFill Implants
EndoVascular Aneurysm Repair
Sponsored by
Shape Memory Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring Abdominal Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: General 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 Anatomical Concomitant iliac artery ectasia or aneurysm Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm. Connective tissue disorder (e.g., Marfan's syndrome) Aneurysmal disease of the descending thoracic aorta Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties EVAR/Procedural 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 Use of an aortic stent graft other than those specified1 for a particular site Planned use of the chosen stent graft outside its instructions for use (IFU) Use of fenestrated stent grafts or chimney techniques Use of the Heli-FX EndoAnchor system Use of embolic devices other than the investigational product to embolize the AAA sac Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries Medical History/Conditions Coagulopathy or uncontrolled bleeding disorder Serum creatinine level >2.5 mg/dL Cerebrovascular accident within 3 months prior to the procedure Myocardial infarction and/or major heart surgery within 3 months prior to the procedure Atrial fibrillation that is not well rate controlled Life expectancy of <2 years post-procedure Known hypersensitivity or contraindication to platinum, iridium, or polyurethane. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC >11,000/mm3) A condition that inhibits radiographic visualization during the implantation procedure History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment

    Control

    Arm Description

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

    Control Arm: Subjects in the control arm will only have an EVAR device implanted.

    Outcomes

    Primary Outcome Measures

    Primary Effectiveness Endpoint
    The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year, and no AAA-related intervention through 1 year.
    Primary Safety Endpoint
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 1, 2023
    Last Updated
    September 1, 2023
    Sponsor
    Shape Memory Medical, Inc.
    Collaborators
    NAMSA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06029660
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    June 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shape Memory Medical, Inc.
    Collaborators
    NAMSA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Aneurysm, Abdominal
    Keywords
    Abdominal Aortic Aneurysm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A prospective, multicenter, randomized, open-label trial.
    Masking
    None (Open Label)
    Masking Description
    Subjects will be blinded to the treatment arm prior to the index procedure; after the procedure, they will be unblinded prior to discharge to prevent unintentional unblinding due to imaging
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Control Arm: Subjects in the control arm will only have an EVAR device implanted.
    Intervention Type
    Device
    Intervention Name(s)
    IMPEDE-FX RapidFill Implants
    Intervention Description
    Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
    Intervention Type
    Procedure
    Intervention Name(s)
    EndoVascular Aneurysm Repair
    Other Intervention Name(s)
    EVAR
    Intervention Description
    Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
    Primary Outcome Measure Information:
    Title
    Primary Effectiveness Endpoint
    Description
    The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year, and no AAA-related intervention through 1 year.
    Time Frame
    1 year
    Title
    Primary Safety Endpoint
    Description
    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
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: General 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 Anatomical Concomitant iliac artery ectasia or aneurysm Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm. Connective tissue disorder (e.g., Marfan's syndrome) Aneurysmal disease of the descending thoracic aorta Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties EVAR/Procedural 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 Use of an aortic stent graft other than those specified1 for a particular site Planned use of the chosen stent graft outside its instructions for use (IFU) Use of fenestrated stent grafts or chimney techniques Use of the Heli-FX EndoAnchor system Use of embolic devices other than the investigational product to embolize the AAA sac Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries Medical History/Conditions Coagulopathy or uncontrolled bleeding disorder Serum creatinine level >2.5 mg/dL Cerebrovascular accident within 3 months prior to the procedure Myocardial infarction and/or major heart surgery within 3 months prior to the procedure Atrial fibrillation that is not well rate controlled Life expectancy of <2 years post-procedure Known hypersensitivity or contraindication to platinum, iridium, or polyurethane. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC >11,000/mm3) A condition that inhibits radiographic visualization during the implantation procedure History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Irene Kuhn
    Phone
    646-369-1591
    Email
    ikuhn@namsa.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peter Miller
    Email
    p.miller@shapemem.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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