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Trial registered on ANZCTR


Registration number
ACTRN12612000009819
Ethics application status
Not yet submitted
Date submitted
16/12/2011
Date registered
4/01/2012
Date last updated
4/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Safety And Effectiveness of the Valet Micro Catheter
Scientific title
A Non-Randomized, Non-blinded, Prospective Feasibility Study to Assess the Safety and Effectiveness of the Volcano Valet Micro Catheter in Patients with Coronary or Peripheral Artery Disease (CAD/PAD) Scheduled for Diagnostic Angiogram or Intervention
Secondary ID [1] 279618 0
Nil
Universal Trial Number (UTN)
U1111-1126-4707
Trial acronym
SAFE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease (CAD) 285412 0
Peripheral Artery Disease (PAD) 285413 0
Condition category
Condition code
Cardiovascular 285593 285593 0 0
Coronary heart disease
Cardiovascular 285594 285594 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Valet Micro Catheter is intended as a single use device during the interventional procedure as a conduit for the exchange/ support of guide wires in the peripheral and coronary vasculatures. Valet micro catheters are indicated to infuse and deliver saline and/or contrast agents. The device is expected to be in the body for less than 15 minutes.
Intervention code [1] 283901 0
Treatment: Devices
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286159 0
Performance: The ability of the Volcano Valet Micro Catheter to track over the guide wire to the target segment and the ability to exchange guide wires through the catheter . The capability to provide guide wire support when in contact with highly stenosed lesions. The ability to torque the catheter within the vascular space to reorient a guide wire.

This composite primary outcome will be assessed by an experienced operator and reported as clinically acceptable on the case report forms and data (number and percent) will be included in the final study report.
Timepoint [1] 286159 0
Continuously during treatment session, up to 15 minutes and captured on the case report forms.
Primary outcome [2] 286162 0
Safety: The assessment and reporting of acute Major Adverse Cardiac Events (MACE)/Major Adverse Events (MAEs) and Unanticipated Adverse Device Effects (UADEs) and their relationship to the study device.

An acute Major Adverse Cardiac Event (MACE) is defined as cardiac death; Non-fatal Target Vessel related Myocardial Infarction (TV-MI), and Target Vessel Revascularization (TVR). An acute Major Adverse Event (MAE) is defined as any acute death and/or major/minor amputation of the study extremity, planned or unplanned. And an Unanticipated Adverse Device Effect (UADE) is defined as any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence.

All MACE, MAEs and UADEs observed during the course of this study and the relationship to the Volcano Valet Micro Catheter will be recorded and reported. All events will be evaluated and reported by the investigator and a final report will be given to the local governing body (IRB or EC), study sponsor and other investigators. The evaluation will include a determination of the severity of the event and the relationship between the event and the Volcano Valet Micro Catheter as unrelated, unlikely, possible, probable, and/or highly probable.
Timepoint [2] 286162 0
Up to patient discharge from hospital.
Secondary outcome [1] 295273 0
Nil
Timepoint [1] 295273 0
Nil

Eligibility
Key inclusion criteria
Stable patients with varying degrees of CAD or PAD scheduled for diagnostic angiogram or intervention.

Patient must be able to read, understand and sign the informed consent document before the planned procedure.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Coronary (CAD) patients will be excluded if they meet any of the following criteria:

Acute Coronary Syndrome (unstable, NSTEMI and STEMI) within 5 days of the procedure.

Patients with unprotected Left Main (LM) disease or ostial lesions of >50%.

Patients at higher risk as determined by the physician.

Patients with an ejection fraction of less than 30% as determined by echo or ventriculogram.

Patients with a saphenous vein graft(s).

Patients who are pregnant or would be at risk from ionizing radiation.

History of or known reaction or sensitivity to contrast agent and is unable to be premedicated.

Peripheral (PAD) patients will be excluded if they meet any of the following criteria:

Acute Coronary Syndrome (unstable, NSTEMI and STEMI) within 5 days of the procedure.

Patients with saphenous vein grafts, if on the ipsilateral side.

Patients with acute limb ischemia.

History of or known reaction or sensitivity to contrast agent and is unable to be premedicated.

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/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 4024 0
New Zealand
State/province [1] 4024 0

Funding & Sponsors
Funding source category [1] 284393 0
Commercial sector/Industry
Name [1] 284393 0
Volcano Corporation
Country [1] 284393 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Volcano Corporation
Address
Corporate Headquarters
3661 Valley Centre Drive, Suite 200
San Diego, CA 92130
Country
United States of America
Secondary sponsor category [1] 283322 0
None
Name [1] 283322 0
Address [1] 283322 0
Country [1] 283322 0
Other collaborator category [1] 260400 0
Hospital
Name [1] 260400 0
Mercy Angiography
Address [1] 260400 0
98 Mountain Road
Epsom
Auckland 1024
Country [1] 260400 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286353 0
Northern X Regional Ethics Committee
Ethics committee address [1] 286353 0
Ethics committee country [1] 286353 0
New Zealand
Date submitted for ethics approval [1] 286353 0
25/11/2011
Approval date [1] 286353 0
Ethics approval number [1] 286353 0

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

Contacts
Principal investigator
Name 33543 0
Address 33543 0
Country 33543 0
Phone 33543 0
Fax 33543 0
Email 33543 0
Contact person for public queries
Name 16790 0
Carrie Vooght
Address 16790 0
1 Fortune Drive
Billerica, MA 01821
Country 16790 0
United States of America
Phone 16790 0
+1 978, 4394333
Fax 16790 0
Email 16790 0
[email protected]
Contact person for scientific queries
Name 7718 0
Dan Redline
Address 7718 0
Volcano Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670
Country 7718 0
United States of America
Phone 7718 0
+1, 916, 2812760
Fax 7718 0
Email 7718 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.