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

April 29, 2021 updated by: Cardio Flow, Inc.

Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease

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,

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32605
        • Cardiovascular Research of North Florida, LLC
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48080
        • Eastlake Cardiovascular, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Orbital Atherectomy Treatment
Device: Balloon Angioplasty
Low pressure balloon angioplasty may be used following atherectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At time of procedure
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious Adverse Events
Time Frame: Through six months
All device and procedure related Serious Adverse Events at 30 days and 6 months
Through six 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.
At time of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardio Flow, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Libra Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Phil Zang, MD, Libra Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 010-031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Descriptive statistics of primary and secondary endpoints may be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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