Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II

Completed · Not applicable

Conditions studied: Total Atherosclerotic Occlusion of Femoral Artery

In brief

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

Key facts

Study ID

NCT01537302

Run by

Avinger, Inc.

People needed

100

Starts

2012-02-01

Expected to finish

2012-06-01

Last updated by the study team

2021-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.