The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.
Study Type
OBSERVATIONAL
Enrollment
50
All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Cardiovascular Institute of the South - Lafayette General South West OBL
Lafayette, Louisiana, United States
Mercy Hospital, Springfield
Chesterfield, Missouri, United States
Procedural Success:
Successful completion of OA (orbital atherectomy) treatment of target lesion via transradial access without serious transradial access (TRA) related events. Serious TRA related events consist of: Serious TRA site bleeding, serious TRA site hematoma, serious radial artery spasm, serious hand ischemia, stroke, Transient Ischemic Attach (TIA), Serious nerve damage, perforation, TRA site pseudoaneurysm.
Time frame: Participants were followed from the baseline procedure through the first site-specific standard of care follow-up visit (7-45 days post-procedure)
Treatment Success:
Treatment success is defined as \<50% residual stenosis post-procedure and without significant angiographic complications without stent placement, or \<30% residual stenosis post-procedure and without significant angiographic complications with stent placement.
Time frame: Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
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Columbia University Medical Center/New York Presbyterian
New York, New York, United States
Sorin Medical, P.C.
New York, New York, United States