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Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks (AAA-SHAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227054
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Shape Memory Medical, Inc.

Study Description
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Brief Summary:
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: IMPEDE-FX Embolization Plug Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Single Center Safety Study
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Device: IMPEDE-FX Embolization Plug
Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of related major adverse events (MAEs) [ Time Frame: 30 days post-procedure ]
    Incidence of related major adverse events (MAEs)

  2. Efficacy - Technical Success [ Time Frame: Immediately after the intervention ]
    Technical success, defined as filling of the residual flow lumen of the AAA sac with investigational products


Secondary Outcome Measures :
  1. Incidence of related major adverse events (MAEs) [ Time Frame: 2 years post-procedure ]
    Incidence of related major adverse events (MAEs)

  2. Incidence of related serious adverse events (SAEs) [ Time Frame: 2 years post-procedure ]
    Incidence of related serious adverse events (SAEs)

  3. Efficacy - Type II endoleaks [ Time Frame: 2 years post-procedure ]
    Incidence of type II endoleaks

  4. Efficacy - Type I and type III endoleaks [ Time Frame: 2 years post-procedure ]
    Incidence of type I and type III endoleaks

  5. Efficacy - AAA sac diameter/volume [ Time Frame: 2 years post-procedure ]
    Change in AAA sac diameter/volume

  6. Efficacy - Open repair [ Time Frame: 2 years post-procedure ]
    Rate of conversion to open AAA repair

  7. Efficacy - Reinterventions [ Time Frame: 2 years post-procedure ]
    Rate of other reinterventions related to the AAA sac growth and/or complications


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years of age
  • A candidate for elective EVAR of an infrarenal aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women

Exclusion Criteria:

  • An inability to provide informed consent
  • Enrolled in another clinical study
  • Concomitant iliac artery ectasia or aneurysm (common iliac artery diameter >24 mm)
  • Patent AAA sac feeding vessels (within the sac) >4 mm in diameter
  • Volume of AAA sac to be filled after stent graft placement <30 mL or >135 mL, based on pre-procedure CTA (i.e. aortic flow volume exclusive of stent graft volume)
  • Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II Stent Graft, or Endologix Ovation Alto Abdominal Stent Graft System to treat the AAA
  • Planned use of the chosen stent graft outside its instructions for use (IFU)
  • Planned use of fenestrated or chimney stent grafts
  • Study participants in which stent graft placement is abandoned for any reason, and/or in which the investigator decides, during the course of the stent graft placement, that the study procedure may not be appropriate
  • Planned use of embolic devices other than the investigational product to embolize the AAA sac
  • 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, or mycotic (infected) aneurysm
  • Aneurysmal disease of the descending thoracic aorta
  • Coagulopathy or uncontrolled bleeding disorder
  • Long-term (>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin K antagonist anticoagulant use
  • 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
  • Unable or unwilling to comply with study follow-up requirements
  • Life expectancy of <2 years post-procedure
  • Known hypersensitivity or contraindication to platinum, iridium, or polyurethane
  • A condition that inhibits radiographic visualization during the implantation procedure
  • History of allergy to contrast medium that cannot be managed medically
  • Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study
  • Pregnant or a 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 study
  • Prisoner or member of other vulnerable population.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227054


Locations
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New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Contact: Elleni Takele    09 307 4949 ext 21976    ElleniT@adhb.govt.nz   
Principal Investigator: Andrew Holden, MB ChB         
Waikato Hospital Recruiting
Hamilton, New Zealand, 3240
Contact: Reenu Arora    +64 7 8430105    reenu@clinicaltrialsnz.com   
Principal Investigator: Manar Khashram, M.D.         
Sponsors and Collaborators
Shape Memory Medical, Inc.
More Information
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Responsible Party: Shape Memory Medical, Inc.
ClinicalTrials.gov Identifier: NCT04227054    
Other Study ID Numbers: CRD1015
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Endoleak
Vascular Diseases
Cardiovascular Diseases
 Aortic Diseases
Postoperative Hemorrhage
Hemorrhage
Pathologic Processes
Postoperative Complications