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Trial record 1 of 2 for:    Cardio Flow, Inc. | United States
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Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD) (FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03365154
Recruitment Status : Completed
First Posted : December 7, 2017
Results First Posted : May 20, 2021
Last Update Posted : May 20, 2021
Libra Medical
Information provided by (Responsible Party):
Cardio Flow, Inc.

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 - 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,

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment Device: Balloon Angioplasty Not Applicable

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 up to 10 patients at 1 - 2 sites. The study will evaluate the safety and effectiveness of the Cardio Flow atherectomy device for plaque removal in de novo target lesions in the peripheral vasculature of the lower extremities. The primary safety endpoint is defined as freedom from a composite of new onset major adverse events through the 30-day follow-up as adjudicated by an independent Clinical Events physician. The primary effectiveness endpoint is defined as the ability of the Cardio Flow Device to achieve a residual diameter stenosis ≤ 50% without adjunctive therapy, determined by Angiographic core lab evaluation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

  2. 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.

Secondary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: Through six months ]
    All device and procedure related Serious Adverse Events at 30 days and 6 months

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

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

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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
Sponsors and Collaborators
Cardio Flow, Inc.
Libra Medical
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Study Director: Phil Zang, MD Libra Medical
  Study Documents (Full-Text)

Documents provided by Cardio Flow, Inc.:
Informed Consent Form  [PDF] December 5, 2017

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Responsible Party: Cardio Flow, Inc.
ClinicalTrials.gov Identifier: NCT03365154    
Other Study ID Numbers: 010-031
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.

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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
Keywords provided by Cardio Flow, Inc.:
Peripheral Artery Disease
Orbital Atherectomy
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases