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

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

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

Study Overview

• Status: Completed
• Conditions: Total Atherosclerotic Occlusion of Femoral Artery
• Intervention / Treatment: Device: CTO crossing in femoropopliteal arteries CONNECT II

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • Leipzig Hospital
  • Muenster, Germany, 48145
    • Muenster Hospital
• Italy
  • Mirano, Italy, 30035
    • Mirano Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Sacramento, California, United States, 95619
      • Sutter Memorial
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Cardiovascular Associates - Alexian Brothers Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46802
      • St. Joseph's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital and Medical Center
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • St. Dominic Hospital
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Jobst Vascular Center
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart
    • El Paso, Texas, United States, 79902
      • El Paso Cardiology Associates
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ocelot System; CTO crossing in femoropopliteal arteries using the Ocelot System	Device: CTO crossing in femoropopliteal arteries CONNECT II; CTO crossing in femoropopliteal arteries using the Ocelot System; Other Names: Chronic TOtal OcclusioN CrossiNg with thE OCelot SysTem II; CONNECT II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Avinger, Inc.
• Investigators: Principal Investigator: Matthew Selmon, MD, Austin Heart Hospital

Publications and helpful links

Helpful Links

• Avinger web site

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Total Occlusion; Lumivascular; Optimal Coherence Tomography
• Other Study ID Numbers: AVI OCT 10005