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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04227054




Registration number
NCT04227054
Ethics application status
Date submitted
10/01/2020
Date registered
13/01/2020
Date last updated
22/01/2020

Titles & IDs
Public title
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
Scientific title
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Single Center Safety Study
Secondary ID [1] 0 0
CRD1015
Universal Trial Number (UTN)
Trial acronym
AAA-SHAPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - IMPEDE-FX Embolization Plug

Experimental: Intervention -


Treatment: Devices: IMPEDE-FX Embolization Plug
Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of related major adverse events (MAEs) - Incidence of related major adverse events (MAEs)
Timepoint [1] 0 0
30 days post-procedure
Primary outcome [2] 0 0
Efficacy - Technical Success - Technical success, defined as filling of the residual flow lumen of the AAA sac with investigational products
Timepoint [2] 0 0
Immediately after the intervention
Secondary outcome [1] 0 0
Incidence of related major adverse events (MAEs) - Incidence of related major adverse events (MAEs)
Timepoint [1] 0 0
2 years post-procedure
Secondary outcome [2] 0 0
Incidence of related serious adverse events (SAEs) - Incidence of related serious adverse events (SAEs)
Timepoint [2] 0 0
2 years post-procedure
Secondary outcome [3] 0 0
Efficacy - Type II endoleaks - Incidence of type II endoleaks
Timepoint [3] 0 0
2 years post-procedure
Secondary outcome [4] 0 0
Efficacy - Type I and type III endoleaks - Incidence of type I and type III endoleaks
Timepoint [4] 0 0
2 years post-procedure
Secondary outcome [5] 0 0
Efficacy - AAA sac diameter/volume - Change in AAA sac diameter/volume
Timepoint [5] 0 0
2 years post-procedure
Secondary outcome [6] 0 0
Efficacy - Open repair - Rate of conversion to open AAA repair
Timepoint [6] 0 0
2 years post-procedure
Secondary outcome [7] 0 0
Efficacy - Reinterventions - Rate of other reinterventions related to the AAA sac growth and/or complications
Timepoint [7] 0 0
2 years post-procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shape Memory Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04227054
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04227054