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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avinger, Inc.
ClinicalTrials.gov Identifier:
NCT01537302
First received: February 15, 2012
Last updated: March 17, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention Phase
Total Atherosclerotic Occlusion of Femoral Artery
Device: CTO crossing in femoropopliteal arteries CONNECT II
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries

Further study details as provided by Avinger, Inc.:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
    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.

  • Primary Efficacy Endpoint [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.


Secondary Outcome Measures:
  • Procedural Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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.

  • Technical Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.

  • Device Performance [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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.

  • Procedural Times [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Evaluation of procedural times.

  • Fluoroscopic Times [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Evaluation of fluoroscopic times.

  • Crossing Times [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Evaluation of crossing times.

  • Use of Assist Devices [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Evaluation of the use of assist devices.

  • Contrast/Flush Volumes [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Evaluation of the contrast/flush volumes.


Enrollment: 201
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537302

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

Additional Information:
No publications provided

Responsible Party: Avinger, Inc.
ClinicalTrials.gov Identifier: NCT01537302     History of Changes
Other Study ID Numbers: AVI OCT 10005
Study First Received: February 15, 2012
Results First Received: March 5, 2015
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Italy: Ethics Committee

Keywords provided by Avinger, Inc.:
Chronic Total Occlusion
Optimal Coherence Tomography
Lumivascular

ClinicalTrials.gov processed this record on August 31, 2015