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
Phase 1
- Conditions
- Prevention/reduction of release or movement of potentially embolic debris from the treatment area and aspiration of such debris prior to blood flow restoration.Blood - Clotting disorders
- Registration Number
- ACTRN12605000277640
- Lead Sponsor
- Genesis Medical Interventional, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
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.
Exclusion Criteria
No exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall physician satisfaction with device performance.[];Overall physician satisfaction with acceptable safety.[]
- Secondary Outcome Measures
Name Time Method Ability of device to access target site[];Ability of device to deploy at target site[];Ability of device to occlude blood flow at target site[];Physician satisfaction with aspiration/ removal of emboli/thrombi from target site.[]