Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000831088
Ethics application status
Approved
Date submitted
1/10/2010
Date registered
5/10/2010
Date last updated
27/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Conformite Europeenne (CE) Mark Study to Demonstrate the Safety and Performance of the Champion Vascular Closure System (VCS)
Scientific title
Femoral Artery closure using the Cardiva Vascular Closure System (VCS) to reduce time to hemostasis and reduce time to ambulation
Secondary ID [1] 252801 0
NIL
Universal Trial Number (UTN)
U1111-1117-3257
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
closure of femoral artery puncture wound 258305 0
Condition category
Condition code
Cardiovascular 258498 258498 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Cardiva Champion VCS consists of a sterile disposable catheter containing a deployable extravascular collagen patch and a clip. The Champion VCS is intended to seal a femoral arterial access site at the end of any procedure that uses a 6French or 7 French cathether to access the femoral artery. This is a one time use device. The procedure of deploying the collagen patch takes less than 3-5 minutes.
Intervention code [1] 257325 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259332 0
The primary efficacy endpoint is the time to achieve arterial hemostasis.
Timepoint [1] 259332 0
Index procedure and 30 day Follow-up post procedure
Primary outcome [2] 259342 0
The primary safety endpoint is the rate of major complications and the secondary safety endpoint is the rate of minor complications.
Timepoint [2] 259342 0
Index procedure and 30 day Follow-up post procedure
Secondary outcome [1] 265796 0
Secondary efficacy endpoint is time to ambulation
Timepoint [1] 265796 0
Ability of the subject to walk 20 feet without evidence of arterial re-bleeding from the access site. The time to ambulation will be measured in hours from the time the Champion catheter is removed until the subject is able to ambulate.
Secondary outcome [2] 265797 0
Time to discharge.
Timepoint [2] 265797 0
The time to discharge is measured from the time the Champion catheter is removed to hospital discharge.
Secondary outcome [3] 265798 0
The time to eligibility for hospital discharge
Timepoint [3] 265798 0
The time to eligibility for hospital discharge is measured from the time the Champion catheter is removed to the time, in the judgment of the investigator, that the subject was eligible for hospital discharge based on institution?s standard of care.

Eligibility
Key inclusion criteria
Clinically indicated for an diagnostic or interventional endovascular procedure anticipated to employ common femoral artery access using a modified Seldinger technique and a 6F or 7F introducer sheath
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key PRE-OPERATIVE EXCLUSION CRITERIA
1.Septicemia or a cutaneous/subcutaneous groin infection
2.Ipsilateral femoral arteriotomy within the previous 30 days
3.Planned arterial access at the same site within the next 90 days
4.Extreme morbid obesity (Body mass index (BMI) greater than 45 kg/m2) or underweight (BMI less than 22 kg/m2)
5.Femoral artery diameter less than 6 mm
6.Difficulty achieving arterial access and/or inserting the introducer sheath at the onset of the procedure (e.g., multiple stick attempts)
7.Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site

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
This is an open-label, prospective, multi-center clinical trial to evaluate the safety and performance of the Cardiva Vascular Closure System.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2944 0
New Zealand
State/province [1] 2944 0
Auckland

Funding & Sponsors
Funding source category [1] 257766 0
Self funded/Unfunded
Name [1] 257766 0
Cardiva Medical, Inc
Country [1] 257766 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Cardiva Medical, Inc.
Address
888 W. Maude Avenue
Sunnyvale, CA 94085
Country
United States of America
Secondary sponsor category [1] 256978 0
None
Name [1] 256978 0
Address [1] 256978 0
Country [1] 256978 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259808 0
Northern X Regional Ethics Committee
Ethics committee address [1] 259808 0
Ministry of Health
3rd Floor, Unisys Building
3rd floor, Unisys building
650 Great South Rd, Penrose
Private Bag 92-522, Wellesley St
Auckland 1061
Ethics committee country [1] 259808 0
New Zealand
Date submitted for ethics approval [1] 259808 0
29/06/2010
Approval date [1] 259808 0
07/07/2010
Ethics approval number [1] 259808 0
NTX/10/06/048

Summary
Brief summary
The Cardiva VCS consists of a sterile disposable catheter containing a deployable extravascular collagen patch and a clip. The Cardiva VCS is intended to seal or close the femoral arterial access sites while reducing time to hemostasis (stop the bleeding process) and time to ambulation (when a person can walk) in subjects who have undergone diagnostic or interventional endovascular procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31723 0
Address 31723 0
Country 31723 0
Phone 31723 0
Fax 31723 0
Email 31723 0
Contact person for public queries
Name 14970 0
Charles Maroney
Address 14970 0
Cardiva Medical, Inc.
888 W. Maude Avenue
Sunnyvale, CA 94058
Country 14970 0
United States of America
Phone 14970 0
1-408-470-7100
Fax 14970 0
1-408-212-9889
Email 14970 0
info@cardivamedical.com
Contact person for scientific queries
Name 5898 0
Marlys Chellew
Address 5898 0
Cardiva Medical, Inc.
888 W. Maude Avenue
Sunnyvale, CA 94058
Country 5898 0
United States of America
Phone 5898 0
1-408-470-7100
Fax 5898 0
1-408-212-9889
Email 5898 0
clinicalaffairs@cardivamedical.com

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.