Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD) (FAST)
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|ClinicalTrials.gov Identifier: NCT03365154|
Recruitment Status : Completed
First Posted : December 7, 2017
Results First Posted : May 20, 2021
Last Update Posted : May 20, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment Device: Balloon Angioplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease|
|Actual Study Start Date :||January 25, 2018|
|Actual Primary Completion Date :||February 22, 2018|
|Actual Study Completion Date :||November 6, 2018|
Experimental: Treatment Group
Patients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device.
Device: Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment
Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.
Other Name: Orbital Atherectomy Treatment
Device: Balloon Angioplasty
Low pressure balloon angioplasty may be used following atherectomy
- Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy [ Time Frame: At time of procedure ]Achievement of ≤ 50% residual stenosis without adjunctive therapy as assessed angiographically on a per lesion basis
- Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment [ Time Frame: 30 days ]
Major adverse events include the following:
- All cause cardiovascular mortality.
- Myocardial infarction (MI): Any newly diagnosed MI post procedure, defined as CK-MB ≥2X upper limit normal (ULN).
- Clinically driven target lesion revascularization (TLR): any repeat percutaneous or surgical intervention to treat objectively documented symptoms of recurrent ischemia attributable to the treated lesion.
- Clinically significant target vessel dissection: NHLBI grade C or greater as confirmed by angiography.
- Clinically significant target vessel perforation: NHLBI Type III as confirmed by angiography.
- Unplanned major target limb amputation: Amputation at the level of the trans-metatarsals or higher that was not previously planned
- Clinically relevant distal embolization: Emboli requiring surgical or medical intervention and/or the presence of symptoms.
- Pseudoaneurysm: disruption of the arterial wall at the treatment site as confirmed by angiography.
- Serious Adverse Events [ Time Frame: Through six months ]All device and procedure related Serious Adverse Events at 30 days and 6 months
- Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy [ Time Frame: At time of procedure ]Ability to achieve <50% residual diameter stenosis with or without adjunctive low-pressure balloon therapy on a per-lesion basis. Operator can follow atherectomy treatment with adjunctive balloon therapy.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365154
|United States, Florida|
|Cardiovascular Research of North Florida, LLC|
|Gainesville, Florida, United States, 32605|
|United States, Michigan|
|Eastlake Cardiovascular, PC|
|Saint Clair Shores, Michigan, United States, 48080|
|Study Director:||Phil Zang, MD||Libra Medical|
Documents provided by Cardio Flow, Inc.:
|Responsible Party:||Cardio Flow, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 7, 2017 Key Record Dates|
|Results First Posted:||May 20, 2021|
|Last Update Posted:||May 20, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Descriptive statistics of primary and secondary endpoints may be shared.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
Peripheral Artery Disease
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases