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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12623000479606p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2023
Date registered
12/05/2023
Date last updated
12/05/2023
Date data sharing statement initially provided
12/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Safety and Effectiveness of an Expandable/Retractable Introducer Sheath
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Scientific title
Safety and Effectiveness of an Expandable/Retractable Introducer Sheath in patients undergoing transcatheter aortic valve replacement
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Secondary ID [1]
309060
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
EXPANDS-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic stenosis
329125
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Condition category
Condition code
Cardiovascular
326100
326100
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Surgery
326716
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a pilot study on the safety and effectiveness of the 3PM ES360 introducer sheath. The 3PM ES360 is an expandable introducer sheath set, comprising of an expandable introducer sheath and compatible dilator. It is intended for use in transcatheter aortic valve replacement (TAVR) procedures. The procedure will be performed by experienced cardiologists on participants who are already scheduled to undergo a TAVR procedure. The procedure should take around one hour. This type of procedure requires a sheath so there would not be any added time for using this sheath, however the procedure may take an additional 10 minutes to collect study data. Participants will be followed up for 30 days post procedure at which point they will be exited from the study.
The study will be monitored by an independent Contract Research Organisation (CRO) who will review all relevant medical notes. The sponsor and CRO will train the study team on the study and the device.
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Intervention code [1]
325507
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Treatment: Devices
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To establish safety and effectiveness of the ES360 sheath in TAVR procedures, as measured by incidences of major vascular complication, and/or major bleeding events according to Valve Academic Research Consortium (VARC3) criteria. Adverse events will be assessed via clinical examination. The study team do not anticipate any adverse events in addition to the standard of care adverse events that may be experienced. Standard risks to a TAVR procedure that you should discuss with your doctor if you have not already include bleeding, blood vessel complications, problems with the replacement valve, stroke, heart rhythm problems, kidney disease, heart attack, infection and death.
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Assessment method [1]
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Timepoint [1]
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48 hours post procedure or earlier if discharged earlier.
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Secondary outcome [1]
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Major vascular complication and/or major bleeding events according to VARC3 criteria. This will be assessed as a composite outcome.
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Assessment method [1]
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Timepoint [1]
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30 days post procedure
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Secondary outcome [2]
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Number of sheath insertions during the TAVR procedure as recorded during the time of the procedure as recorded in the participant's surgical records and the study worksheets
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Assessment method [2]
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Timepoint [2]
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During the procedure
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Secondary outcome [3]
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Minor vascular complications assessed using VARC 3 criteria
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Assessment method [3]
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Timepoint [3]
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30 days post procedure
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Secondary outcome [4]
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Minor bleeding events assessed using VARC 3 criteria
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Assessment method [4]
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Timepoint [4]
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30 days post procedure
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Secondary outcome [5]
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Incidence of death
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Assessment method [5]
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Timepoint [5]
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30 days post procedure
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Eligibility
Key inclusion criteria
1. Indicated for TAVR procedure incorporating a compatible device
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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
1. Prior intervention/stenting in the aorta and/or ilio-femoral arteries
2. Severely calcified or highly tortuous peripheral vasculature
3. Medical, social, or psychological condition that in the opinion of an Investigator precludes the subject from appropriate consent
4. Concurrently participating in another cardiovascular device trial
5. Subject refuses a blood transfusion
6. Recent cerebrovascular accident or transient ischemic attack (within 90 days)
7. Recent emergency surgery for any reason (within 30 days)
8. Any percutaneous peripheral interventional procedure performed within 30 days prior to the procedure
9. Aged under 18 at time of consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Due to the low number of study participants only limited, descriptive data analysis will be possible. A detailed Statistical Analysis Plan (SAP) will be prepared prior to performing any final analysis. The plan will define populations for analysis, outline all data handling conventions and specify all statistical methods to be used analysis of the data. The SAP may include modifications of the overview of statistical analysis described in the protocol. Data generated during this study may be useful to inform sample size selection for future studies.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
9/06/2023
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Actual
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Date of last participant enrolment
Anticipated
9/07/2024
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [2]
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
39628
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3168 - Clayton
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Recruitment postcode(s) [2]
39629
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3004 - Melbourne
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Three Peaks Medical Pty Ltd
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Address [1]
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c/o 27 Beulah Rd, Norwood, SA 5067
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Three Peaks Medical Pty Ltd
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Address
c/o 27 Beulah Rd, Norwood, SA 5067
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
314998
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Country [1]
314998
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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55 Commercial Rd, Melbourne VIC 3004
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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11/05/2023
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Approval date [1]
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Ethics approval number [1]
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Summary
Brief summary
The purpose of this study is to establish preliminary clinical safety, effectiveness, and useability data for the ES360 expandable/retractable introducer sheath in transcatheter aortic valve replacement (TAVR) procedures.
It is anticipated that the device will reduce major vascular injury and major bleeding events associated with transfemoral TAVR procedures.
The device is also hypothesised to reduce the number of sheath insertions required during the procedure when used with TAVR delivery systems.
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Trial website
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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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Dr Anthony Walton
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Address
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Alfred Health
55 Commercial Road, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61390763269
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Anthony Walton
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Address
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Alfred Health
55 Commercial Road, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61390763269
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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
Name
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Dr Anthony Walton
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Address
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Alfred Health
55 Commercial Road, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61390763269
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Fax
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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