Peripheral Arterial DiseaseFASTNCT03365154
Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)
A study testing Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment and Balloon Angioplasty in people with Peripheral Arterial Disease, run by Cardio Flow, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment and Balloon Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jan 2018to 6 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cardiovascular Research of North Florida, LLC
Gainesville, Florida, 32605
Eastlake Cardiovascular, PC
Saint Clair Shores, Michigan, 48080
About this study
Official title: 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,
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment, Balloon Angioplasty
- Keywords
- Peripheral Artery Disease, Atherectomy, Orbital Atherectomy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio Flow FreedomFlow™ Orbital Atherectomy System treatmentDevice
Also called Orbital Atherectomy Treatment
Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.
Balloon AngioplastyDevice
Low pressure balloon angioplasty may be used following atherectomy
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Patients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device. Receives: Device: Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment; Device: Balloon Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy
Achievement of ≤ 50% residual stenosis without adjunctive therapy as assessed angiographically on a per lesion basis
Measured: At time of procedure
Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment
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.
Measured: 30 days
Secondary outcomes (2)
Serious Adverse Events
All device and procedure related Serious Adverse Events at 30 days and 6 months
Measured: Through six months
Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy
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.
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start25 Jan 2018
- Primary completion22 Feb 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardio Flow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Responsible party
- Sponsor
- Investigators
- Phil Zang, MD, Study director, Libra Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365154
- Sponsor's protocol ID
- 010-031
- Acronym
- FAST
- Status last verified
- Mar 2021
- First submitted
- 1 Dec 2017
- Last updated
- 20 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Descriptive statistics of primary and secondary endpoints may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT03365154
- Acronym / sponsor ID
- FAST / 010-031
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Artery Disease, Atherectomy, Orbital Atherectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cardio Flow, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Libra Medical
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Posted 20 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment, Device: Balloon AngioplastyPatients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio Flow FreedomFlow™ Orbital Atherectomy System treatmentAlso: Orbital Atherectomy TreatmentOcclusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty. | Device | Treatment Group |
| Balloon AngioplastyLow pressure balloon angioplasty may be used following atherectomy | Device | Treatment Group |
Primary outcome
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.
2 secondary outcomes
Serious Adverse Events
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Descriptive statistics of primary and secondary endpoints may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phil Zang, MD study director
Libra Medical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment and Balloon Angioplasty in people with Peripheral Arterial Disease, run by Cardio Flow, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy (time frame: At time of procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2021.