Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000906358
Ethics application status
Approved
Date submitted
17/06/2017
Date registered
20/06/2017
Date last updated
24/04/2020
Date data sharing statement initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective study to evaluate the safety and performance of a shape memory polymer foam embolization device for arterial or venous embolization of the peripheral vasculature system.
Scientific title
A prospective study to evaluate the safety and performance of a shape memory polymer foam embolization device for arterial or venous embolization of the peripheral vasculature system by assessing rates of serious adverse events and unanticipated serious adverse device effects from the day of procedure through 30 days post-procedure.
Secondary ID [1] 292220 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
arterial or venous condition requiring embolization 303714 0
Condition category
Condition code
Cardiovascular 303088 303088 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The shape memory polymer foam embolization device is intended for use by physicians trained and experienced in embolization techniques, angiographic techniques, and interventional procedures. In this single arm study, each study subject will undergo a single index procedure for permanent device implantation by a qualified interventional radiolologist. The pushable polymeric embolization device is designed to be delivered to the target vessel using a guidewire through a standard catheter, guided by angiography. The plug delivery, deployment and verification procedures require about 10 minutes.
Intervention code [1] 298381 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302471 0
Adverse events reported by site will be reviewed by medical monitor to assess primary endpoint of freedom from incidence of serious adverse events and unanticipated serious adverse device effects.
Timepoint [1] 302471 0
30 days post-procedure.
Secondary outcome [1] 336112 0
Technical success defined as embolization of the target vessel after deployment of the study device.
Timepoint [1] 336112 0
Post-procedure

Eligibility
Key inclusion criteria
Study Participant is greater than or equal to 18 years of age and less than or equal to 75 years of age;
Study Participant is considered a candidate for arterial or venous embolization of the peripheral vasculature;
Study Participant has a target vessel >2 mm and <9 mm in diameter, measured during angiographic imaging.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study Participant has an inability to provide written informed consent;
Study Participant has inappropriate anatomy of the vasculature for the safe access and/or the deployment of the study device,
Study Participant has known hypersensitivity or contraindication to nickel or nitinol;
Study Participant has a condition that inhibits radiographic visualization during the implantation procedure;
Study Participant has a history of allergy to contrast medium that cannot be managed medically;
Study Participant has an uncontrolled co-morbid medical condition that would adversely affect participation in the Study;
Study Participant is pregnant or a lactating female.



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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2017
Actual
1/08/2017
Date of last participant enrolment
Anticipated
Actual
6/05/2019
Date of last data collection
Anticipated
Actual
19/06/2019
Sample size
Target
20
Accrual to date
Final
11
Recruitment outside Australia
Country [1] 8995 0
New Zealand
State/province [1] 8995 0
Auckland

Funding & Sponsors
Funding source category [1] 296761 0
Commercial sector/Industry
Name [1] 296761 0
Shape Memory Medical Inc
Country [1] 296761 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Shape Memory Medical Inc
Address
807 Aldo Avenue,
Suite 109
Santa Clara, CA 95054
Country
United States of America
Secondary sponsor category [1] 295743 0
None
Name [1] 295743 0
Address [1] 295743 0
Country [1] 295743 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297988 0
The Northern A Health and Disability Ethics Committee:
Ethics committee address [1] 297988 0
Ethics committee country [1] 297988 0
New Zealand
Date submitted for ethics approval [1] 297988 0
Approval date [1] 297988 0
30/05/2017
Ethics approval number [1] 297988 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75666 0
A/Prof Andrew Holden
Address 75666 0
Auckland City Hospital
2 Park Road, Grafton
Auckland 1023
Country 75666 0
New Zealand
Phone 75666 0
+ 64 (09) 3074949
Fax 75666 0
Email 75666 0
a.holden@auckland.ac.nz
Contact person for public queries
Name 75667 0
Edward Ruppel
Address 75667 0
Shape Memory Medical, Inc.
807 Aldo Avenue,
Suite 109,
Santa Clara, CA 95054
Country 75667 0
United States of America
Phone 75667 0
+1 408 649 5175
Fax 75667 0
Email 75667 0
ted@shapemem.com
Contact person for scientific queries
Name 75668 0
Edward Ruppel
Address 75668 0
Shape Memory Medical, Inc.
807 Aldo Avenue,
Suite 109,
Santa Clara, CA 95054
Country 75668 0
United States of America
Phone 75668 0
+1 408 649 5175
Fax 75668 0
Email 75668 0
ted@shapemem.com

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.