Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II

Not Applicable

Completed

Brief Summary: Evaluation of the safety and effectiveness of the Ocelot System to provide OCT-assisted orientation while simultaneously crossing totally occluded femoropopliteal arteries.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Patient is willing and able to provide informed consent
Patient is willing and able to comply with the study protocol
Patient is > 18 years old
Patient has peripheral arterial disease requiring revascularization as evidenced by CTA, MRA or angiography
Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate
Target vessel is ≥ 3.0 mm in diameter
Patient has Rutherford Classification of 2-5
Lesion is recalcitrant to guidewire crossing

Exclusion Criteria

Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated
Patient has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications
Patient is pregnant or lactating
Patient has a co-existing disease or medical condition contraindicating percutaneous intervention
Target vessel is severely calcified as evidenced by angiography
Target lesion is in a bypass graft
Target lesion is in a stent (i.e., in-stent restenosis)
Patient has had a procedure on the target limb within 7 days
Patient has had a procedure on the target limb within the past 30 days and is unstable
Patient has a planned surgical or interventional procedure within 30 days after the study procedure
Patient is simultaneously participating in an investigational device study for treatment of peripheral vascular disease
Patient has a planned amputation of the target limb
Patient has a history of bleeding diathesis, coagulopathy or will refuse blood transfusion in cases of emergency

Arm && Interventions

Group	Intervention	Description
Ocelot System	CTO crossing in femoropopliteal arteries CONNECT II	CTO crossing in femoropopliteal arteries using the Ocelot System

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint	Day 0	Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.
Primary Safety Endpoint	Day 30	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.

Secondary Outcome Measures

Name	Time	Method
Procedural Success	Day 0	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.
Fluoroscopic Time	Day 0	Total time fluoroscopy was used during the procedure.
Procedural Time	Day 0	Total time of the procedure from the insertion of the catheter to its removal following treatment of the CTO
Technical Success	Day 0	Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.
CTO Crossing Time	Day 0	Time required to cross the CTO during the procedure.
Use of Assist Devices	Day 0	Comparison of the crossing times for the Ocelot System alone versus the Ocelot System with assist devices.
Device Performance	Day 0	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.
Contrast/Flush Volumes	Day 0	Contrast and flush volumes are presented

Locations (17): St. Joseph's Hospital
🇺🇸
Fort Wayne, Indiana, United States
Sutter Memorial
🇺🇸
Sacramento, California, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Cardiovascular Associates - Alexian Brothers Medical Center
🇺🇸
Elk Grove Village, Illinois, United States
St. John Hospital and Medical Center
🇺🇸
Detroit, Michigan, United States
Detroit Medical Center
🇺🇸
Detroit, Michigan, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Jobst Vascular Center
🇺🇸
Toledo, Ohio, United States
Bryn Mawr Hospital
🇺🇸
Bryn Mawr, Pennsylvania, United States
Austin Heart
🇺🇸
Austin, Texas, United States
El Paso Cardiology Associates
🇺🇸
El Paso, Texas, United States
Leipzig Hospital
🇩🇪
Leipzig, Germany
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
Muenster Hospital
🇩🇪
Muenster, Germany
Mirano Hospital
🇮🇹
Mirano, Italy
St. Dominic Hospital
🇺🇸
Jackson, Mississippi, United States
Deborah Heart and Lung Center
🇺🇸
Browns Mills, New Jersey, United States