Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000771055
Ethics application status
Not yet submitted
Date submitted
14/09/2010
Date registered
15/09/2010
Date last updated
15/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Chocolate Balloon Catheter for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
Scientific title
In patients with infrainguinal arterial disease, can the Chocolate Balloon Catheter be used safely and effectively for ballon dilatation during percutaneous transluminal revascularization procedures?
Secondary ID [1] 252690 0
None
Universal Trial Number (UTN)
Trial acronym
Chocolate FIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arterial disease of the infrainguinal arteries 258175 0
Condition category
Condition code
Cardiovascular 258357 258357 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Percutaneous Transluminal Angioplasty (PTA)- During this procedure a balloon, such as the Chocolate Balloon, is placed across a narrowing in a blood vessel of the leg. The balloon is inflated temporarily to open up the narrowing by pushing on the wall of the vessel to restore blood flow in that part of the artery. After inflation, the balloon is removed and no part of the balloon catheter is left behind in the artery. The balloon can be inflated for up to a few minutes and it may be inflated more than one time. The procedure will usually take about 30 minutes to complete, but a more complicated blockage can take one hour or more.
Intervention code [1] 257196 0
Treatment: Devices
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259205 0
Technical Success: defined as <50% residual stenosis without flow-limiting dissection at the target lesion based on physician review of the imaging taken at the end of the procedure. An idependent core lab will also asses the images for this outcome.
Timepoint [1] 259205 0
at the end of the Percutaneous Transluminal Angioplasty (PTA) procedure
Secondary outcome [1] 265591 0
percentage of patients free from Major Adverse Events (MAE) including death, index limb major amputation and target lesion revascularization based upon a review of the patient chart and a physical exam
Timepoint [1] 265591 0
patients are monitored through hospital discharge and then at follow-up visits to be conducted at 1 month, 6 months and 12 months after the procedure
Secondary outcome [2] 265592 0
Device Success: defined as <50% residual stenosis without flow-limiting dissection at the target lesion based on physician review of the imaging taken after the Chocolate Balloon is used.
Timepoint [2] 265592 0
after use of the investigational device
Secondary outcome [3] 265593 0
primary patency - defined as freedom from hemodynamically significant restenosis at the target lesion without the need of target lesion revascularization. This will be asssesed by an independent core lab review of the follow-up images.
Timepoint [3] 265593 0
at follw-up vists conducted 6 months and 12 months after the procedure

Eligibility
Key inclusion criteria
Intermittent claudication or critical limb ischemia (Rutherford 2-5)
De novo or restenotic stenosis (=50%) or occlusion in the infrainguinal arteries, including superficial femoral artery (SFA), popliteal, and infrapopliteal arteries
Reference vessel diameter 2.0-6.0 mm
Lesion length =150mm
Lesion must be successfully crossed with a guidewire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute limb ischemia
Non-atherosclerotic disease (e.g. embolism, Buerger's disease, vasculitis)
Patient requires any concomitant percutaneous endovascular procedure in other vasculature e.g. renal, coronary, carotid, etc.
Myocardial infarction or stroke within 30 days prior to the procedure
Any planned surgical intervention/procedure within 30 days of the study procedure
In-stent restenosis proximal to or in the target lesion
Target lesion distal to a newly implanted stent

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
Who is / are masked / blinded?



Intervention assignment
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
15/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2907 0
New Zealand
State/province [1] 2907 0
Auckland

Funding & Sponsors
Funding source category [1] 257652 0
Commercial sector/Industry
Name [1] 257652 0
Quattro Vascular Pte Ltd
Country [1] 257652 0
Singapore
Primary sponsor type
Commercial sector/Industry
Name
Quattro Vascular Pte Ltd
Address
2 Shenton Way #18-01
SGX Centre 1
Singapore 068804
Country
Singapore
Secondary sponsor category [1] 256869 0
Commercial sector/Industry
Name [1] 256869 0
TriReme Medical, Inc
Address [1] 256869 0
7060 Koll Center Parkway
Suite 300
Pleasanton, CA 94566
Country [1] 256869 0
United States of America

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259661 0
Ethics committee address [1] 259661 0
Ethics committee country [1] 259661 0
Date submitted for ethics approval [1] 259661 0
17/09/2010
Approval date [1] 259661 0
Ethics approval number [1] 259661 0
Ethics committee name [2] 259662 0
Ethics committee address [2] 259662 0
Ethics committee country [2] 259662 0
Germany
Date submitted for ethics approval [2] 259662 0
01/11/2010
Approval date [2] 259662 0
Ethics approval number [2] 259662 0

Summary
Brief summary
This study is intended to evaluate the use of the Chocolate Balloon Catheter to treat arterial disease in the infrainguinal arteries.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 31640 0
Address 31640 0
Country 31640 0
Phone 31640 0
Fax 31640 0
Email 31640 0
Contact person for public queries
Name 14887 0
Ern Tims
Address 14887 0
7060 Koll Center Parkway
Suite 300
Pleasanton, CA 94566
Country 14887 0
United States of America
Phone 14887 0
+1925-931-1300 ext 212
Fax 14887 0
Email 14887 0
[email protected]
Contact person for scientific queries
Name 5815 0
Erin Tims
Address 5815 0
7060 Koll Center Parkway
Suite 300
Pleasanton, CA 94566
Country 5815 0
United States of America
Phone 5815 0
+1925-931-1300 ext 212
Fax 5815 0
Email 5815 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.