Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001248954
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 Efficacy of the CARDIVA VASCADE Vascular Closure System (VCS) versus Manual Compression
Scientific title
Femoral Artery closure using the Cardiva VASCADE Vascular Closure System (VCS) to reduce time to hemostasis and reduce time to ambulation and hospital discharge versus manual compression in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing 6 Fr or 7 Fr procedural sheaths
Secondary ID [1] 273528 0
NIL
Universal Trial Number (UTN)
U1111-1126-2507
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Closure of femoral artery puncture wound 279328 0
Condition category
Condition code
Cardiovascular 279514 279514 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 6 or 7 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] 283841 0
Treatment: Devices
Comparator / control treatment
VASCADE VCS / Manual Compression
Randomization will be 2:1 treatment device to control ratio

Manual compression is the current standard treatment for post-procedure vascular management and involves compression applied by hand to the vascular access site until hemostasis is achieved, according to the Institution's guidelines.
Control group
Active

Outcomes
Primary outcome [1] 286083 0
The primary effectiveness endpoint is the time to achieve arterial hemostasis following device removal for Cardiva VASCADE VCS and sheath removal for manual compression
Timepoint [1] 286083 0
Index procedure
Primary outcome [2] 286084 0
The primary safety endpoint is the 30-day rate of combined access site-related major complications. Major complications include:
- Access site-related bleeding requiring transfusion - assessment of site-related bleeding is via direct observation and excessive blood loss would be determined via Institutional guidelines
- Vascular injury requiring repair - prolonged bleeding would require further assessment for vascular injury using techniques such as ultrasound imaging
- New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention - compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram
- Access site-related infection - assessment made based on subject symptoms and physical exam
- New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair - assessment made based on subject symptoms and physical exam
- Permanent access site-related nerve injury (greater than 30 days) - based on subject symptoms and physical exam
Timepoint [2] 286084 0
Index procedure and 30 day Follow-up post procedure
Secondary outcome [1] 295092 0
The secondary effectiveness endpoint is time to ambulation.
Timepoint [1] 295092 0
Elapsed time between device removal for Cardiva VASCADE VCS and sheath removal for manual compression, and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site
Secondary outcome [2] 295094 0
Time to discharge eligibility
Timepoint [2] 295094 0
Elapsed time between device removal for Cardiva VASCADE VCS and sheath removal for manual compression, and when subject is medically able to be discharged based solely on access site assessment.
Secondary outcome [3] 295095 0
Time to hospital discharge
Timepoint [3] 295095 0
Elapsed time between device removal for Cardiva VASCADE VCS and sheath removal for manual compression, 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 6 Fr or 7 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After each subject has been determined to meet all enrollment criteria, their eligibility criteria will be entered into an electronic database. The subject's randomization assignment then will be determined via central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization assignment will be determined by the database system based on the randomization scheme submitted by our biostatistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is an open-label, prospective, randomized, controlled, multi-center clinical trial to evaluate the safety and effectiveness of the Cardiva VASCADE Vascular Closure System (VCS) versus Manual Compression for the management of the femoral arteriotomy after percutaneous endovascular procedures
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
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3991 0
United States of America
State/province [1] 3991 0
Indiana

Funding & Sponsors
Funding source category [1] 284317 0
Self funded/Unfunded
Name [1] 284317 0
Cardiva Medical, Inc.
Country [1] 284317 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] 283261 0
None
Name [1] 283261 0
Address [1] 283261 0
Country [1] 283261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286281 0
St. Vincent's HREC
Ethics committee address [1] 286281 0
Ethics committee country [1] 286281 0
Australia
Date submitted for ethics approval [1] 286281 0
Approval date [1] 286281 0
02/09/2011
Ethics approval number [1] 286281 0
160/10

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

Contacts
Principal investigator
Name 33482 0
Address 33482 0
Country 33482 0
Phone 33482 0
Fax 33482 0
Email 33482 0
Contact person for public queries
Name 16729 0
Charles Maroney, President & CEO
Address 16729 0
Cardiva Medical, Inc.
888 W. Maude Avenue
Sunnyvale, CA 94085
Country 16729 0
United States of America
Phone 16729 0
+1 408 470-7118
Fax 16729 0
+1 408 212-9889
Email 16729 0
[email protected]
Contact person for scientific queries
Name 7657 0
Marlys Chellew
Address 7657 0
Cardiva Medical, Inc.
888 W. Maude Avenue
Sunnyvale, CA 94085
Country 7657 0
United States of America
Phone 7657 0
+1 916 303-0879
Fax 7657 0
+1 408 212-9889
Email 7657 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.