NCT01537302

Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II

A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Avinger, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Atherosclerotic Occlusion of Femoral Artery

Interventions

Type	Name	Description
DEVICE	CTO crossing in femoropopliteal arteries CONNECT II	CTO crossing in femoropopliteal arteries using the Ocelot System

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-02-23
• Last updated: 2021-03-22
• Results posted: 2015-03-18

Locations

17 sites across 3 countries: United States, Germany, Italy