Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001247965
Ethics application status
Approved
Date submitted
3/12/2011
Date registered
6/12/2011
Date last updated
29/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Study to Demonstrate the Safety and Performance of the VASCADE 5F Vascular Closure System (VCS)
Scientific title
Femoral Artery closure using the Cardiva VASCADE 5F Vascular Closure System (VCS) to reduce time to hemostasis and reduce time to ambulation and hospital discharge in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing 5 French procedural sheaths
Secondary ID [1] 273527 0
NIL
Universal Trial Number (UTN)
U1111-1126-2427
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Closure of femoral artery puncture wound 279327 0
Condition category
Condition code
Cardiovascular 279513 279513 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Cardiva VASCADE VCS consists of a sterile disposable catheter containing a deployable extravascular collagen patch and a clip. The VASCADE VCS is intended to seal a femoral arterial access site at the end of any procedure that uses a 5 French introducer sheath 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] 283840 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286081 0
The primary effectiveness endpoint is the time to achieve arterial hemostasis.
Timepoint [1] 286081 0
Index procedure
Primary outcome [2] 286082 0
The primary safety endpoint is the 30-day rate of combined access site-related major complications.
Timepoint [2] 286082 0
Index procedure and 30 day Follow-up post procedure
Secondary outcome [1] 295089 0
The secondary effectiveness endpoint is time to ambulation.
Timepoint [1] 295089 0
Elapsed time between device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site
Secondary outcome [2] 295090 0
Time to discharge eligibility
Timepoint [2] 295090 0
Elapsed time between device removal and when subject is medically able to be discharged based solely on access site assessment.
Secondary outcome [3] 295091 0
Time to hospital discharge
Timepoint [3] 295091 0
Elapsed time between device removal and when subject actually is discharged from the hospital, as recorded on the discharge order.

Eligibility
Key inclusion criteria
Clinically indicated for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5 Fr introducer sheath
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key Pre-Operative Exclusion Criteria
1. Active systemic or a cutaneous infection
2. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids
3. Ipsilateral femoral arteriotomy within the previous 30 days
4. Planned endovascular procedure within the next 30 days
5. Unilateral or bilateral lower extremity amputation(s)
6. Extreme morbid obesity [Body Max Index (BMI) greater than 45 kg/m2] or underweight (BMI less than 22 kg/m2)
7. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, "back“wall stick”, etc.)
8. 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)
All patients meeting the study enrollment criteria will be invited to participate until the enrollment is completed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is an open-label, prospective, single-site clinical trial to evaluate the safety and effectiveness of the 5 Fr Cardiva VASCADE Vascular Closure System (VCS)
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284316 0
Self funded/Unfunded
Name [1] 284316 0
Cardiva Medical, Inc.
Country [1] 284316 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] 283260 0
None
Name [1] 283260 0
Address [1] 283260 0
Country [1] 283260 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286280 0
St. Vincent?s HREC, St. Vincent?s Hospital (Melbourne)
Ethics committee address [1] 286280 0
PO Box 2900
Fitzroy Victoria 3065
Ethics committee country [1] 286280 0
Australia
Date submitted for ethics approval [1] 286280 0
Approval date [1] 286280 0
08/11/2011
Ethics approval number [1] 286280 0
1/11/0127

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

Contacts
Principal investigator
Name 33481 0
Address 33481 0
Country 33481 0
Phone 33481 0
Fax 33481 0
Email 33481 0
Contact person for public queries
Name 16728 0
Charles Maroney, President & CEO
Address 16728 0
Cardiva Medical, Inc.
888 W. Maude Avenue
Sunnyvale, CA 94085
Country 16728 0
United States of America
Phone 16728 0
+1 408 470-7118
Fax 16728 0
+1 408 212-9889
Email 16728 0
[email protected]
Contact person for scientific queries
Name 7656 0
Marlys Chellew
Address 7656 0
Cardiva Medical, Inc.
888 W. Maude Avenue
Sunnyvale, CA 94085
Country 7656 0
United States of America
Phone 7656 0
+1 916 303-0879
Fax 7656 0
+1 408 212-9889
Email 7656 0
[email protected]

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.