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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12620000773932
Ethics application status
Approved
Date submitted
15/05/2020
Date registered
28/07/2020
Date last updated
5/08/2022
Date data sharing statement initially provided
28/07/2020
Date results information initially provided
5/08/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Safety and Feasibility Evaluation of the Arterica Closure Device designed for the closure of artery access sites following Endovascular procedures
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Scientific title
A Safety and Technical Feasibility Evaluation of the Arterica Closure Device for Large-Bore Vascular Closure Following Interventional Procedures
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Secondary ID [1]
301476
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CLP-0001
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Universal Trial Number (UTN)
U1111-1251-4334
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Trial acronym
CloSure Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
large-bore common femoral access site
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Condition category
Condition code
Surgery
315444
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The device used is the Arterica Closure Device (ACD). The ACD is a medical device used to close large-bore vascular access sites following endovascular or interventional procedures. It is a handheld device operated by a trained clinician or doctor. The device has a handle and a nose with an extended tip. The tip of the device is inserted into the access site where it brings together the surrounding tissue and closes the wound.
The investigational procedure will be performed in an operation room or catherization lab, by an experienced and trained device operator.
The ADC procedure will take approximately 30 minutes.
The device must be used per the Instructions for Use. The sponsor will ensure all device operators are trained.
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Intervention code [1]
317533
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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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Technical Success will be evaluated based upon successful common femoral artery closure without the need for vascular exposure. This includes successful deployment and withdrawal of the closure device itself. Outcome will be confirmed by the surgeon.
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Assessment method [1]
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Timepoint [1]
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Technical Success will be evaluated immediately post procedure.
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Primary outcome [2]
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Safety will be evaluated as freedom from major complications occurring in the target limb and directly attributable to the Arterica Large-Bore Closure Device.
The following are considered major complications. These complications will be assessed and reported by the Investigator through a combination of medical record review and subject evaluation.
Access site-related bleeding that is attributable to failure of or sub-optimal performance of the Arterica Closure Device and that results in significant blood transfusion (greater than or equal to 4 units) or irreversible end-organ failure or death
Access site-related infection requiring intravenous antibiotics and/or extended hospitalization
Access site-related nerve injury attributable to the Arterica Closure Device that is permanent (lasting greater than 30 days) or requires surgical repair
New onset ipsilateral lower extremity ischemia that originates with the common femoral artery, is attributable to the Arterica Closure Device, causes a threat to the viability of the limb, and requires surgical repair or additional percutaneous intervention
Vascular injury attributable to the Arterica Closure Device requiring surgical repair or stent-graft
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Assessment method [2]
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Timepoint [2]
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Safety will be evaluated 30-days post procedure.
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Secondary outcome [1]
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A secondary evaluation will be evaluated as freedom from *minor complications occurring in the target limb and directly attributable to the Arterica Large-Bore Closure Device.
Follow are considered Minor complications. These complication will be assessed and reported by the Investigator through a combination of medical record review and subject evaluation.
Pseudoaneurysm treated with ultrasound-guided compression, ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection
Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ damage
Failure of percutaneous access site common femoral artery closure resulting in interventional (e.g. use of another type of common femoral artery closure device or stent-graft) or surgical correction and without need for significant blood transfusion (greater than or equal to 4 units) and not associated with irreversible end-organ failure or death
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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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Eligibility
Key inclusion criteria
Subject is >18 years of age at time of consent
Subject is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedures involving access through the common femoral artery
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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
Subject is pregnant or lactating
Subject has known bleeding disorder
Subject has recent history of common femoral artery closure with any common femoral artery closure device or any open procedure in the target groin.
Subject has recent history of common femoral artery closure with manual compression.
Subject unable to ambulate.
Subject has a unilateral or bilateral lower extremity amputation
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
Study was stopped early due to Covid travel and other staff restrictions limiting ability to support and conduct the study.
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Date of first participant enrolment
Anticipated
31/08/2020
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Actual
2/06/2021
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Date of last participant enrolment
Anticipated
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Actual
7/12/2021
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Date of last data collection
Anticipated
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Actual
19/05/2022
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Sample size
Target
21
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Accrual to date
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Final
4
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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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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Arterica, Inc.
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Address [1]
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3650 N. Laughlin Road
Santa Rosa, CA 95403
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Arterica, Inc.
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Address
3650 N. Laughlin Road
Santa Rosa, CA 95403
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
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None
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern B Health and Disability Ethics Committees (HDEC)
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Ethics committee address [1]
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133 Molesworth Street
Thorndon
Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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09/07/2020
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Approval date [1]
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22/10/2020
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Ethics approval number [1]
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Summary
Brief summary
The primary objective of this study is to evaluate the safety and technical feasibility of the Arterica Closure Device (ACD). The device is being used in this study so that the Sponsor (Arterica) and study staff can learn about the potential use of the product. This device has been designed to close large-bore vascular (blood vessels) access sites following endovascular or interventional procedures. Researchers are evaluating if the device is safe to use and if it shows potential of closing large-bore access sites.
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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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Mr Andrew Hill
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Address
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Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
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Country
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New Zealand
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Phone
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+64 9 307 4949
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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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Mr Andrew Hill
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Address
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Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
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Country
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New Zealand
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Phone
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+64 09 367 0000
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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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Mr Andrew Hill
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Address
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Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
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Country
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New Zealand
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Phone
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+64 09 367 0000
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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
IPD will not be shared outside of this study.
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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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
379757-(Uploaded-15-07-2022-03-30-36)-Basic results summary.docx
Plain language summary
No
As a first-in-human study the study is a safety an...
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