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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06550986




Registration number
NCT06550986
Ethics application status
Date submitted
9/08/2024
Date registered
13/08/2024

Titles & IDs
Public title
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
Scientific title
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
Secondary ID [1] 0 0
CRD1043
Universal Trial Number (UTN)
Trial acronym
FLAGSHIP_NZL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Dissection 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - False Lumen Embolization System, IMPEDE-FX RapidFill

Experimental: Experimental: Intervention - Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill


Treatment: Devices: False Lumen Embolization System, IMPEDE-FX RapidFill
Embolization of the false lumen of an aortic dissection
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Technical success
Timepoint [1] 0 0
Immediately after the intervention
Primary outcome [2] 0 0
Major adverse events
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
All-cause mortality and dissection-related mortality
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Serious adverse events
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Change in false lumen thrombosis from baseline
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Change in true lumen/aorta size ratio from baseline
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Change in aorta size from baseline
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Rate of dissection-related reinterventions
Timepoint [6] 0 0
2 years

Eligibility
Key inclusion criteria
=18 years of age. A candidate for false lumen (FL) embolization with a type B dissection, and no prior primary entry tear/TL treatment, OR A candidate for FL embolization with a type B or type A dissection, in whom the primary entry tear/TL was treated in a previous procedure, and is now presenting with a FL requiring treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
An inability to provide informed consent. Enrolled in another clinical study other than a registry. Hyperacute or acute aortic dissection (<15 days from symptom onset). Untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before FL treatment with the investigational product).

Vascular disease, aortic rupture, and/or anatomy and/or dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the FL.

Prior treatment of the FL. Planned use of investigational devices to treat the primary entry tear and/or TL.

Absence of/inability to create a reentry tear/fenestration adequately positioned and large enough to allow introducer sheath access into the FL.

Planned use of FL embolic devices other than the investigational product. Prior abdominal aortic aneurysm (AAA) treatment. Planned concomitant major surgery (e.g., gastrointestinal surgery). Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos syndrome). Coagulopathy or uncontrolled bleeding disorder. Serum creatinine level >2.5 mg/dL (within 90 days prior to the procedure). Cerebrovascular accident within 90 days prior to the procedure. Myocardial infarction and/or major heart surgery within 90 days 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 postprocedure. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.

A condition that inhibits radiographic visualization during the study procedure and planned follow-up imaging.

History of allergy to contrast medium that cannot be managed medically. Uncontrolled comorbid medical condition, including mental health issues, that, in the opinion of the investigator, would adversely affect participation in the study.

Participant is planning to become pregnant or is currently pregnant or lactating. For participants 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
15
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
Trial website
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
Peter Miller, M.S.
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06550986