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
Scientific title
A Safety and Technical Feasibility Evaluation of the Arterica Closure Device for Large-Bore Vascular Closure Following Interventional Procedures
Secondary ID [1] 301476 0
CLP-0001
Universal Trial Number (UTN)
U1111-1251-4334
Trial acronym
CloSure Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
large-bore common femoral access site 317336 0
Condition category
Condition code
Surgery 315444 315444 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 317533 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323736 0
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.

Timepoint [1] 323736 0
Technical Success will be evaluated immediately post procedure.
Primary outcome [2] 324084 0
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
Timepoint [2] 324084 0
Safety will be evaluated 30-days post procedure.
Secondary outcome [1] 382759 0
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
Timepoint [1] 382759 0
30-days post procedure

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study was stopped early due to Covid travel and other staff restrictions limiting ability to support and conduct the study.
Date of first participant enrolment
Anticipated
31/08/2020
Actual
2/06/2021
Date of last participant enrolment
Anticipated
Actual
7/12/2021
Date of last data collection
Anticipated
Actual
19/05/2022
Sample size
Target
21
Accrual to date
Final
4
Recruitment outside Australia
Country [1] 22539 0
New Zealand
State/province [1] 22539 0
Auckland

Funding & Sponsors
Funding source category [1] 305639 0
Commercial sector/Industry
Name [1] 305639 0
Arterica, Inc.
Country [1] 305639 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Arterica, Inc.
Address
3650 N. Laughlin Road
Santa Rosa, CA 95403
Country
United States of America
Secondary sponsor category [1] 306090 0
None
Name [1] 306090 0
None
Address [1] 306090 0
None
Country [1] 306090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305925 0
Northern B Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 305925 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 305925 0
New Zealand
Date submitted for ethics approval [1] 305925 0
09/07/2020
Approval date [1] 305925 0
22/10/2020
Ethics approval number [1] 305925 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102086 0
Mr Andrew Hill
Address 102086 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 102086 0
New Zealand
Phone 102086 0
+64 9 307 4949
Fax 102086 0
Email 102086 0
[email protected]
Contact person for public queries
Name 102087 0
Andrew Hill
Address 102087 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 102087 0
New Zealand
Phone 102087 0
+64 09 367 0000
Fax 102087 0
Email 102087 0
[email protected]
Contact person for scientific queries
Name 102088 0
Andrew Hill
Address 102088 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 102088 0
New Zealand
Phone 102088 0
+64 09 367 0000
Fax 102088 0
Email 102088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be shared outside of this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 379757-(Uploaded-15-07-2022-03-30-36)-Basic results summary.docx
Plain language summaryNo As a first-in-human study the study is a safety an... [More Details]

Documents added automatically
No additional documents have been identified.