Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II
NCT ID: NCT01537302
Last Updated: 2021-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2012-02-29
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ocelot System
CTO crossing in femoropopliteal arteries using the Ocelot System
CTO crossing in femoropopliteal arteries CONNECT II
CTO crossing in femoropopliteal arteries using the Ocelot System
Interventions
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CTO crossing in femoropopliteal arteries CONNECT II
CTO crossing in femoropopliteal arteries using the Ocelot System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Avinger, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Matthew Selmon, MD
Role: PRINCIPAL_INVESTIGATOR
Austin Heart Hospital
Arne Schwindt, MD
Role: PRINCIPAL_INVESTIGATOR
Muenster Hospital
Locations
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Arkansas Heart Hospital
Little Rock, Arkansas, United States
Sutter Memorial
Sacramento, California, United States
Cardiovascular Associates - Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
St. Joseph's Hospital
Fort Wayne, Indiana, United States
Detroit Medical Center
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
St. Dominic Hospital
Jackson, Mississippi, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Jobst Vascular Center
Toledo, Ohio, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Austin Heart
Austin, Texas, United States
El Paso Cardiology Associates
El Paso, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Leipzig Hospital
Leipzig, , Germany
Muenster Hospital
Münster, , Germany
Mirano Hospital
Mirano, , Italy
Countries
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Related Links
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Avinger web site
Other Identifiers
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AVI OCT 10005
Identifier Type: -
Identifier Source: org_study_id
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