- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03365154
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
10
Phase
- 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
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Florida
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Gainesville, Florida, United States, 32605
- Cardiovascular Research of North Florida, LLC
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Michigan
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Saint Clair Shores, Michigan, United States, 48080
- Eastlake Cardiovascular, PC
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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
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 |
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.
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Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.
Other Names:
Low pressure balloon angioplasty may be used following atherectomy
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What is the study measuring?
Primary Outcome Measures
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
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Achievement of ≤ 50% residual stenosis without adjunctive therapy as assessed angiographically on a per lesion basis
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At time of procedure
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Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment
Time Frame: 30 days
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Major adverse events include the following:
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serious Adverse Events
Time Frame: Through six months
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All device and procedure related Serious Adverse Events at 30 days and 6 months
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Through six months
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Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy
Time Frame: At time of procedure
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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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At time of procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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)
January 25, 2018
Primary Completion (ACTUAL)
February 22, 2018
Study Completion (ACTUAL)
November 6, 2018
Study Registration Dates
First Submitted
December 1, 2017
First Submitted That Met QC Criteria
December 5, 2017
First Posted (ACTUAL)
December 7, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 20, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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