Status:
COMPLETED
Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)
Lead Sponsor:
Cardio Flow, Inc.
Collaborating Sponsors:
Libra Medical
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Feasibility Clinical Trial of the Cardio Flow FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST Trial) is a prospective non-randomized single arm study that will enroll ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03365154
Start Date
January 25 2018
End Date
November 6 2018
Last Update
May 20 2021
Active Locations (2)
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1
Cardiovascular Research of North Florida, LLC
Gainesville, Florida, United States, 32605
2
Eastlake Cardiovascular, PC
Saint Clair Shores, Michigan, United States, 48080