Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.
The purpose of this clinical study is to evaluate the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing chronic total occlusions (CTOs) in femoropopliteal arteries. The Ocelot Catheter is a minimally invasive percutaneous device that is designed to traverse arterial occlusions through the use of spiral wedges contained in the distal tip of the device. The device is also equipped with an OCT (optical coherence tomography) imaging fiber that provides directional orientation and an intravascular view of the vessel wall and target lesion. The Ocelot Catheter is used in conjunction with standard endovascular devices and as an adjunct to fluoroscopic guidance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
CTO crossing in femoropopliteal arteries using the Ocelot System
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Sutter Memorial
Sacramento, California, United States
Primary Safety Endpoint
No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.
Time frame: Day 30
Primary Efficacy Endpoint
Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.
Time frame: Day 0
Procedural Success
Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections.
Time frame: Day 0
Technical Success
Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.
Time frame: Day 0
Device Performance
Device performance as assessed by Investigator's input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO.
Time frame: Day 0
Procedural Time
Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO
Time frame: Day 0
Fluoroscopic Time
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Cardiovascular Associates - Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
St. Joseph's Hospital
Fort Wayne, Indiana, United States
Detroit Medical Center
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
St. Dominic Hospital
Jackson, Mississippi, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Jobst Vascular Center
Toledo, Ohio, United States
...and 7 more locations
Total time fluoroscopy was used during the procedure.
Time frame: Day 0
CTO Crossing Time
Time required to cross the CTO during the procedure.
Time frame: Day 0
Use of Assist Devices
Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices.
Time frame: Day 0
Contrast/Flush Volumes
Contrast and flush volumes are presented
Time frame: Day 0