Clinical trial NCT01537302: Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II
Official title: A Non-randomized Study of the Avinger Ocelot System Used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Atherosclerotic Occlusion of Femoral Artery
Keywords: Chronic Total Occlusion
Optimal Coherence Tomography
Lumivascular
Lead sponsor: Avinger, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: Day 30
measure: Primary Efficacy Endpoint
timeFrame: Day 0
Secondary outcomes:
measure: Procedural Success
timeFrame: Day 0
measure: Technical Success
timeFrame: Day 0
measure: Device Performance
timeFrame: Day 0
measure: Procedural Time
timeFrame: Day 0
measure: Fluoroscopic Time
timeFrame: Day 0
measure: CTO Crossing Time
timeFrame: Day 0
measure: Use of Assist Devices
timeFrame: Day 0
measure: Contrast/Flush Volumes
timeFrame: Day 0
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Sacramento
country: United States
facility: Sutter Memorial
state: California
city: Elk Grove Village
country: United States
facility: Cardiovascular Associates - Alexian Brothers Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: St. Joseph's Hospital
state: Indiana
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Jackson
country: United States
facility: St. Dominic Hospital
state: Mississippi
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Toledo
country: United States
facility: Jobst Vascular Center
state: Ohio
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: El Paso
country: United States
facility: El Paso Cardiology Associates
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Leipzig
country: Germany
facility: Leipzig Hospital
city: Muenster
country: Germany
facility: Muenster Hospital
city: Mirano
country: Italy
facility: Mirano Hospital
Study officials:
affiliation: Austin Heart Hospital
name: Matthew Selmon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muenster Hospital
name: Arne Schwindt, MD
role: PRINCIPAL_INVESTIGATOR
References: