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

February 15, 2012
March 17, 2015
February 2012
June 2012   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT01537302 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Total Atherosclerotic Occlusion of Femoral Artery
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
Experimental: Treatment arm
Intervention: Device: CTO crossing in femoropopliteal arteries CONNECT II
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   Italy
 
NCT01537302
AVI OCT 10005
Yes
Avinger, Inc.
Avinger, Inc.
Not Provided
Principal Investigator: Matthew Selmon, MD Austin Heart Hospital
Principal Investigator: Arne Schwindt, MD Muenster Hospital
Avinger, Inc.
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP