Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel patency following treatment. Safety will be assessed by monitoring adverse events throughout the study. Safety and Efficacy will be evaluated by comparing study results to established performance criteria,

Key facts

Study ID

NCT03365154

Run by

Cardio Flow, Inc.

People needed

10

Starts

2018-01-25

Expected to finish

2018-11-06

Last updated by the study team

2021-05-20

Who can join

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

You may qualify if…

• Candidate for percutaneous endovascular intervention in the lower extremity;
• Disease is located in peripheral arteries between 2mm and 5mm diameter;
• Ankle brachial index ≤ 0.90;
• Rutherford classification 2,3,4 or 5;
• De novo target lesion has ≥ 50% stenosis;
• Target lesion length ≤ 200 cm;
• At least 1 patent tibial vessel runoff;
• Written, signed informed consent.

You may not qualify if…

• Female not using adequate contraception or is breastfeeding;
• Rutherford class 0 1, and 6;
• target lesion within a native graft,
• in-stent restenosis,
• ≤ 50% occlusion, or chronic total occlusion;
• history of vascular surgery or interventional procedure on index limb within 30 days prior to procedure, or planned procedure within 30 days after index procedure, lesion in contralateral limb requiring intervention during index procedure or within 30 days of index procedure;
• known or suspected systemic infection;
• unstable coronary disease; significant kidney disease requiring dialysis;
• evidence of aneurysmal target vessel within past 2 months;
• evidence of intracranial or GI bleeding, intracranial aneurysm, MI or stroke within 2 months of baseline evaluation;
• history of heparin-induced thrombocytopenia;
• contraindication to anti-platelet, anticoagulant, or thrombolytic therapy;
• uncorrected bleeding disorders;
• thrombolytic therapy within 2 weeks of index procedure;
• life expectancy less than 12 months;
• unwilling or unable to comply with follow-up requirements;
• intraoperative complications due to the use of a marketed device prior to use of the atherectomy system;
• currently participating in an investigational drug or other device study that has not completed primary endpoint;
• unable to tolerate standard interventional procedures if the study device is not effective.

Where it is running

• Cardiovascular Research of North Florida, LLC — Gainesville, Florida, United States
• Eastlake Cardiovascular, PC — Saint Clair Shores, Michigan, United States

Full record on ClinicalTrials.gov

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