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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06029660
Registration number
NCT06029660
Ethics application status
Date submitted
1/09/2023
Date registered
8/09/2023
Titles & IDs
Public title
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
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Scientific title
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
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Secondary ID [1]
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CRD 1029
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Aneurysm, Abdominal
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - IMPEDE-FX RapidFill Implants
Treatment: Surgery - EndoVascular Aneurysm Repair
Experimental: Treatment - Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
Active comparator: Control - Control Arm: Subjects in the control arm will only have an EVAR device implanted.
Treatment: Devices: IMPEDE-FX RapidFill Implants
Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
Treatment: Surgery: EndoVascular Aneurysm Repair
Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Effectiveness Endpoint : AAA Sac Regression at 1 year
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Assessment method [1]
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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.
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Timepoint [1]
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1 year
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Primary outcome [2]
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Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days
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Assessment method [2]
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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
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Timepoint [2]
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30 days
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/04/2024
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Date of last participant enrolment
Anticipated
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Date of last data collection
Anticipated
1/06/2030
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
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Recruitment outside Australia
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Arizona
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New York
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Ohio
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Wisconsin
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Netherlands
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Gelderland
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Netherlands
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Tilburg
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New Zealand
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State/province [14]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Shape Memory Medical, Inc.
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Address
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Other collaborator category [1]
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Other
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Name [1]
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NAMSA
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06029660
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Marc Schermerhorn, M.D.
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Address
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Beth Israel Deaconess Medical Center
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Irene Kuhn
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Address
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Phone
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646-369-1591
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06029660