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Trial registered on ANZCTR


Trial ID
ACTRN12605000277640
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
2/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physician Preference/ Performance Evaluation of F.A.S.T.-LVG for the Temporary Occlusion of Blood Flow in Patients During Interventional Procedures in Saphenous Vein Grafts and Coronary Arteries
Scientific title
Physician Preference/ Performance Evaluation of F.A.S.T.-LVG for the Temporary Occlusion of Blood Flow in Patients During Interventional Procedures in Saphenous Vein Grafts and Coronary Arteries
Secondary ID [1] 133 0
Genesis Medical Interventional, Inc.: GMI-LVG-050501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention/reduction of release or movement of potentially embolic debris from the treatment area and aspiration of such debris prior to blood flow restoration. 365 0
Condition category
Condition code
Blood 427 427 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Temporary proximal occlusion of saphenous vein grafts and coronary arteries during standard intervetional procedures.
Intervention code [1] 321 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 490 0
Overall physician satisfaction with device performance.
Timepoint [1] 490 0
Primary outcome [2] 491 0
Overall physician satisfaction with acceptable safety.
Timepoint [2] 491 0
Secondary outcome [1] 1052 0
Ability of device to access target site
Timepoint [1] 1052 0
Secondary outcome [2] 1053 0
Ability of device to deploy at target site
Timepoint [2] 1053 0
Secondary outcome [3] 1054 0
Ability of device to occlude blood flow at target site
Timepoint [3] 1054 0
Secondary outcome [4] 1055 0
Physician satisfaction with aspiration/ removal of emboli/thrombi from target site.
Timepoint [4] 1055 0

Eligibility
Key inclusion criteria
Patient with evidence of myocardial ischemia; with 50-100% stenosed coronary or SVG; with target vessel 2.5-5.5 mm; with 2 cm vessel proximal to lesion; with only one vessel requiring treatment, with adquate renal function; no angioplasty or stenting within past 24 hrs.
Minimum age
21 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
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
Other
Other design features
Coronary Arteries and Saphenous Vein Graft groups
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 156 0
United States of America
State/province [1] 156 0

Funding & Sponsors
Funding source category [1] 480 0
Commercial sector/Industry
Name [1] 480 0
Genesis Medical Interventional, Inc.
Address [1] 480 0
Country [1] 480 0
Primary sponsor type
Commercial sector/Industry
Name
Genesis Medical Interventional, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 387 0
None
Name [1] 387 0
None
Address [1] 387 0
Country [1] 387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1457 0
Aukland City Hospital
Ethics committee address [1] 1457 0
Aukland
Ethics committee country [1] 1457 0
New Zealand
Date submitted for ethics approval [1] 1457 0
Approval date [1] 1457 0
Ethics approval number [1] 1457 0
Ethics committee name [2] 1458 0
Waikato Hospital
Ethics committee address [2] 1458 0
Hamilton
Ethics committee country [2] 1458 0
New Zealand
Date submitted for ethics approval [2] 1458 0
Approval date [2] 1458 0
Ethics approval number [2] 1458 0
Ethics committee name [3] 1459 0
Christchurch Hospital
Ethics committee address [3] 1459 0
Christchurch
Ethics committee country [3] 1459 0
New Zealand
Date submitted for ethics approval [3] 1459 0
Approval date [3] 1459 0
Ethics approval number [3] 1459 0

Summary
Brief summary
Physician satisfaction with device performance in preventing blood clots/debris from traveling from treatment site to the heart or head.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35359 0
Address 35359 0
Country 35359 0
Phone 35359 0
Fax 35359 0
Email 35359 0
Contact person for public queries
Name 9510 0
Jose de Castro
Address 9510 0
Genesis Medical Interventional Inc.
Suite 103 652 Bair Island Road
Redwood City CA 94063
Country 9510 0
United States of America
Phone 9510 0
+1 650 7141695
Fax 9510 0
+1 650 3677668
Email 9510 0
jose@genesismedical.net
Contact person for scientific queries
Name 438 0
Jose de Castro
Address 438 0
Genesis Medical Interventional Inc.
Suite 103 652 Bair Island Road
Redwood City CA 94063
Country 438 0
United States of America
Phone 438 0
+1 650 5876272
Fax 438 0
+1 650 3677668
Email 438 0
jose@genesismedical.net