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
Scientific title
Safety and Effectiveness of an Expandable/Retractable Introducer Sheath in patients undergoing transcatheter aortic valve replacement
Secondary ID [1] 309060 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EXPANDS-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic stenosis 329125 0
Condition category
Condition code
Cardiovascular 326100 326100 0 0
Diseases of the vasculature and circulation including the lymphatic system
Surgery 326716 326716 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325507 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333968 0
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.
Timepoint [1] 333968 0
48 hours post procedure or earlier if discharged earlier.
Secondary outcome [1] 419995 0
Major vascular complication and/or major bleeding events according to VARC3 criteria. This will be assessed as a composite outcome.
Timepoint [1] 419995 0
30 days post procedure
Secondary outcome [2] 421293 0
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
Timepoint [2] 421293 0
During the procedure
Secondary outcome [3] 421294 0
Minor vascular complications assessed using VARC 3 criteria
Timepoint [3] 421294 0
30 days post procedure
Secondary outcome [4] 421295 0
Minor bleeding events assessed using VARC 3 criteria
Timepoint [4] 421295 0
30 days post procedure
Secondary outcome [5] 421296 0
Incidence of death
Timepoint [5] 421296 0
30 days post procedure

Eligibility
Key inclusion criteria
1. Indicated for TAVR procedure incorporating a compatible device
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/06/2023
Actual
Date of last participant enrolment
Anticipated
9/07/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24120 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 24121 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 39629 0
3004 - Melbourne
Recruitment postcode(s) [2] 39628 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 313265 0
Commercial sector/Industry
Name [1] 313265 0
Three Peaks Medical Pty Ltd
Country [1] 313265 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Three Peaks Medical Pty Ltd
Address
c/o 27 Beulah Rd, Norwood, SA 5067
Country
Australia
Secondary sponsor category [1] 314998 0
None
Name [1] 314998 0
Address [1] 314998 0
Country [1] 314998 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312495 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 312495 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 312495 0
Australia
Date submitted for ethics approval [1] 312495 0
11/05/2023
Approval date [1] 312495 0
Ethics approval number [1] 312495 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124866 0
Dr Anthony Walton
Address 124866 0
Alfred Health
55 Commercial Road, Melbourne VIC 3004
Country 124866 0
Australia
Phone 124866 0
+61390763269
Fax 124866 0
Email 124866 0
awalton@alfred.org.au
Contact person for public queries
Name 124867 0
Dr Anthony Walton
Address 124867 0
Alfred Health
55 Commercial Road, Melbourne VIC 3004
Country 124867 0
Australia
Phone 124867 0
+61390763269
Fax 124867 0
Email 124867 0
awalton@alfred.org.au
Contact person for scientific queries
Name 124868 0
Dr Anthony Walton
Address 124868 0
Alfred Health
55 Commercial Road, Melbourne VIC 3004
Country 124868 0
Australia
Phone 124868 0
+61390763269
Fax 124868 0
Email 124868 0
awalton@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.