Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II (CONNECTII)

Avinger

Status

Completed

Conditions

Total Atherosclerotic Occlusion of Femoral Artery

Treatments

Device: CTO crossing in femoropopliteal arteries CONNECT II

Study type

Interventional

Funder types

Industry

Identifiers

NCT01537302

AVI OCT 10005

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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