Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000588291
Ethics application status
Approved
Date submitted
27/04/2009
Date registered
15/07/2009
Date last updated
20/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of new femoral artery closure device to assist haemostasis in patients following cardiac catheterisation.
Scientific title
Safety and feasibilty study of new arterial closure device in patients following a Cardiac compared with literature controls for safety and time to haemostasis.
Secondary ID [1] 287955 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
CAT VI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 4673 0
Condition category
Condition code
Cardiovascular 4979 4979 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the Catheterization lab, provided no bleeding around the introducer sheath is observed and appropriate sterile technique is used, the Boomerang Catalyst VI Wire will be inserted through the indwelling 6F or 7F introducer sheath at the puncture site according to the Instructions for Use. After temporary hemostasis is achieved, imaging of the vessel will be performed to confirm correct placement of the device disc immediately prior to deployment of the extravascular collagen patch; the puncture site will then be observed for oozing blood and or signs of hematoma formation. At some point after hemostasis and prior to discharge, another ultrasound of the vessel will be performed and a digital image recorded as a baseline for the appearance of the collagen patch in proximity to the arteriotomy site.
Intervention code [1] 4435 0
Treatment: Devices
Comparator / control treatment
time to haemostasis using manual compression. no control group. Compared with average times for manual compression. As this is a safety and feasibilty study, no comparision will be made with other closure device times for haemostasis. A further Randomised Controlled Trial (RCT) will then be undertaken.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5826 0
The primary safety endpoint is the incidence of major adverse events of the image-guided investigational device did not exceed those of manual compression alone as reported in literature.
Timepoint [1] 5826 0
discharge and 30 days post procedure
Primary outcome [2] 5827 0
The primary effectiveness endpoint is to demonstrate a superior (reduced) hold time till haemostasis with the Boomerang Catalyst VI System image-guided, extravascular patch as compared to literature controls for manual compression alone.
Timepoint [2] 5827 0
discharge and 30 days post procedure
Secondary outcome [1] 241831 0
the successful imaging of deployed Boomerang Catalyst VI disc and collagen patch prior to deployment, by clinician assessment
Timepoint [1] 241831 0
post procedure
Secondary outcome [2] 241832 0
device success rate, by clinician assessment and vascular ultrasound
Timepoint [2] 241832 0
post procedure
Secondary outcome [3] 241833 0
time to ambulation eligibility, by clinicain assessment
Timepoint [3] 241833 0
post procedure
Secondary outcome [4] 241834 0
time to discharge eligibility, by clinician assessment
Timepoint [4] 241834 0
discharge

Eligibility
Key inclusion criteria
clinically scheduled for angiogram or angioplasty, able to ambulate >20 feet,
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
current infection, femoral arteriotomy in <30 days, femoral arrter closure device in past 180 days, low platelets, high international normalised ratio (INR), anaemia, intra-procedural bleeding, high activated clotting time (ACT), A suspected intraluminal thrombus, hematoma, pseudo-aneurysm, or AV fistula of the target artery or 'multiple wall' arterial puncture.

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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
6/11/2009
Date of last participant enrolment
Anticipated
Actual
16/11/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 1741 0
New Zealand
State/province [1] 1741 0

Funding & Sponsors
Funding source category [1] 4855 0
Commercial sector/Industry
Name [1] 4855 0
Cardiva Medical Inc
Country [1] 4855 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cardiva Medical Inc
Address
2585 Leghorn Street
Mountain View,
California 94043
Country
United States of America
Secondary sponsor category [1] 4393 0
Hospital
Name [1] 4393 0
Christchurch Hospital
Address [1] 4393 0
Cardiology Department
Christchurch Hospital
Private bag 4710
Christchurch, 8140
Country [1] 4393 0
New Zealand
Secondary sponsor category [2] 291123 0
Hospital
Name [2] 291123 0
Auckland City Hospital
Address [2] 291123 0
Auckland
New Zealand
Country [2] 291123 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6913 0
Multi-Regional Ethics Committee
Ethics committee address [1] 6913 0
Ministry of Health
133 Molesworth Street
Wellington 6145
New Zealand
Ethics committee country [1] 6913 0
New Zealand
Date submitted for ethics approval [1] 6913 0
01/05/2009
Approval date [1] 6913 0
22/07/2009
Ethics approval number [1] 6913 0
MEC/09/05/055

Summary
Brief summary
The Boomerang Catalyst VI System is designed to help in controlling bleeding (gaining haemostasis) following an arterial puncture made for the purpose of completing a coronary angiogram or angioplasty (procedures done in the cardiac catheter laboratory to look for or treat narrowings in the coronary arteries). This puncture is usually made in the femoral artery in the groin. Often haemostasis is gained by manual compression (using the fingers or hand) and the literature reported average time for this technique will be compared the time it takes to gain haemostasis using the wire and collagen patch components of the device, as well as compression. There are several other closure devices used in New Zealand, and more than 50% of procedures would now have these used.

The device is placed into the femoral artery in the catheter laboratory once the angiogram has been completed, followed by a minimum of one minute of manual compression.

100 consecutive patients at 5 sites (20 per site) will be enrolled. The time taken to control the bleeding, time till the participant can stand and walk around, and the time till they are fit for discharge will be recorded. Also adverse, serious adverse and device adverse events will be recorded. Participants will be seen prior to discharge and again at 30 days and at these time points ultrasound will be used to assess the position of the collagen patch to the puncture site.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29537 0
Dr James Blake
Address 29537 0
Christchurch Hospital
cardiology Department
Private bag 4710
Christchurch
Country 29537 0
New Zealand
Phone 29537 0
+64 3 364 0640
Fax 29537 0
Email 29537 0
james.blake@cdhb.health.nz
Contact person for public queries
Name 12784 0
Mrs Catherine Cruickshank
Address 12784 0
Cardiology Department
Christchurch Hospital
Private bag 4710
Christchurch 8140
Country 12784 0
New Zealand
Phone 12784 0
+64 3 3601096
Fax 12784 0
Email 12784 0
catheric@cdhb.govt.nz
Contact person for scientific queries
Name 3712 0
Dr Dr James Blake
Address 3712 0
Cardiology Department
Christchurch Hospital
Private bag 4710
Christchurch 8140
Country 3712 0
New Zealand
Phone 3712 0
+64 3 3640 640
Fax 3712 0
Email 3712 0
james.blake@cdhb.govt.nz

No information has been provided regarding IPD availability


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.