To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.
Prospective, multi-center, non-randomized single-arm study of the Wingman Catheter to cross a single infrainguinal peripheral chronic total occlusion (CTO). Safety and effectiveness will be evaluated during the index procedure through 30-day follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Endovascular CTO crossing
Adventist St. Helena Hospital
St. Helena, California, United States
Number of Lesions With Successful CTO Crossing Assessed by Angiography
While using the Wingman device, successful CTO crossing is identified by successful guidewire placement in the distal true lumen confirmed by angiography with no clinically significant perforations. Assessment by angiography with results reviewed by an independent core lab.
Time frame: Intraprocedural
Major Adverse Event (MAE) Rate
Occurrence of significant in-hospital or 30-day MAEs.
Time frame: Assessed from the time of the procedure through 30 days
Rate of Clinically Significant Perforations
Occurrence of clinically significant perforation, after Wingman CTO crossing and PTA of lesion, confirmed by angiography, evaluated by angiographic core lab
Time frame: Will be assessed from the time of the procedure through 30 days
Lesion Success
Lesion success, defined as attainment of \<50% final residual stenosis of the target lesion using any percutaneous method
Time frame: Intraprocedural
Procedure Success Rate
Procedure success, defined as device success and the absence of in-hospital MAEs, clinically significant perforation, clinically significant embolization or Grade C or greater dissection not resolved by visual estimate
Time frame: Approximately 24 hours post procedure
Incidence of In-hospital AE or MAE
Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device
Time frame: Intraprocedural
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Total Procedural Time
Evaluation of total procedural time
Time frame: Approximately 24 hours post procedure
Device Procedural Time
Evaluation of procedure time associated with use of the investigational device.
Time frame: Approximately 24 hours post procedure
Contrast Use
Evaluation of total procedural contrast volume use
Time frame: Approximately 24 hours post procedure
Fluoroscopic Time
Evaluation of total procedural fluoroscopic time
Time frame: Approximately 24 hours post procedure