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Peripheral Arterial DiseaseFASTIINCT03635190

Evaluation of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease

A study testing Orbital Circumferential Atherectomy in people with Peripheral Arterial Disease, run by Cardio Flow, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities. 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?
Orbital Circumferential Atherectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
13 sitesUnited States
Study dates
17 Dec 2018to 13 Oct 2021
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

  • Age ≥ 18 years old.
  • Subject is a candidate for percutaneous endovascular intervention for peripheral vascular disease in the lower extremity.
  • Objective hemodynamic criteria that subject has a resting ankle-brachial index (ABI) ≤ 0.90 OR a resting toe-brachial index (TBI) of ≤ 0.80 OR ankle pressure of ≤70 mmHg.
  • Clinical presentation of lifestyle limiting claudication, rest pain and/or ischemic wounds as characterized by Rutherford Classification 2, 3, 4, or 5.
  • Disease is located in the common femoral, superficial femoral, popliteal, tibioperoneal, anterior tibial, posterior tibial, and/or peroneal arteries.
  • De novo target lesion(s) with stenosis ≥70% by visual estimation and/or
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  • Lesion(s) treated by percutaneous transluminal angioplasty (PTA) and/or atherectomy ≥3 months prior with a restenosis ≥70% by visual estimation.
  • Up to three lesions can be treated at the index procedure provided the cumulative total lesion length is ≤ 20 cm AND all lesions are in the same target leg.
  • Target reference vessel diameter (proximal to and distal to target lesion) is 2 to 8 mm by angiographic visual estimation.
  • At least one patent vessel run-off to the ankle or foot at baseline.
  • The target lesion(s) can be successfully crossed with a commercially available 0.014" atherectomy guidewire without any complications during wiring procedure.
  • Subject signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure.
  • Subject must be excluded from participation in this study if any of the following criteria are met:

Who cannot join

  • Is female with childbearing potential not taking adequate contraceptives or is currently breastfeeding.
  • Target lesion is within a native graft or synthetic graft.
  • Target lesion is an in-stent restenosis.
  • Target lesion is a chronic total occlusion (CTO) with occlusion length greater than 10 cm and/or with wire crossed sub-intimally. CTO wire placement in true lumen must be confirmed via Intra-vascular ultrasound (IVUS) prior to enrollment.
  • Subject has significant stenosis or occlusion of inflow tract (upstream disease) not successfully treated during the index procedure and prior to treatment of the target lesion.
  • Intra-operative (intra-procedure) clinical or angiographic complication (other than non-flow limiting dissections) attributed to the use of a currently marketed device prior to introduction of the Cardio Flow atherectomy drive shaft.
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  • Evidence or history of aneurysmal target vessel.
  • Clinical/angiographic evidence of distal embolization prior to intervention.
  • History of an endovascular procedure or open vascular surgery on the index limb within 30 days prior to the index procedure. Endovascular procedure or open vascular surgery on the non-index limb cannot be staged within 2 weeks prior to the index procedure.
  • Planned endovascular or surgical procedure prior to the subject's 30 day follow up.
  • Signs and symptoms of systemic infection (temperature of ≥ 38.0° Celsius and/or white blood cell count (WBC) of ≥ 12,000 cells/µL) at the time of assessment; Note: If infection is adequately treated and controlled (temperature < 38.0° C and WBC < 12,000 cells/µL) patient may be enrolled.
  • Unstable coronary artery disease or other comorbid condition(s) that, in the judgment of the physician precludes safe percutaneous intervention.
  • Significant acute or chronic kidney disease with a creatinine level > 2.5mg/dL and/or requiring dialysis.
  • Evidence of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stoke within 2 months of index procedure.
  • Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  • Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
  • Heparin-induced thrombocytopenia (HIT) not able to use Bivalirudin.
  • Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2, known coagulopathy, or international normalized ratio (INR) > 1.8.
  • Evidence of thrombus within target lesion or thrombolytic therapy within 2 weeks of the index procedure.
  • Has life expectancy < 12 months in the opinion of the investigator.
  • Subject is unwilling or unable to comply with the follow-up study requirements.
  • Subject is currently participating in an investigational drug or another investigational device exemption (IDE) study.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Orlando Heart and Vascular Institute

    Altamonte Springs, Florida, 32714

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756

  • Palm Vascular Center of Broward, LLC

    Fort Lauderdale, Florida, 33312

  • Cardiovascular Research of North Florida, LLC

    Gainesville, Florida, 32605

  • Advanced Cardiac & Vascular Centers for Amputation Prevention

    Grand Rapids, Michigan, 49525

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256

  • Texas Tech University Medical Center

    Lubbock, Texas, 79430

  • Cardiovascular Institute of the South

    Opelousas, Louisiana, 70570

  • Cardiology Partners Clinical Research Institute

    Palm Beach Gardens, Florida, 33410

  • Orion Medical Research, LLC

    Pasadena, Texas, 77505

  • Eastlake Cardiovascular, PC

    Saint Clair Shores, Michigan, 48080

  • Cardiovascular Associates of East Texas

    Tyler, Texas, 75702

Other trials in United States

About this study

Official title: Evaluation of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease

To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.

Read the detailed description

The FAST II study is a prospective, multi-center, non-randomized single-arm trial designed to evaluate the safety and effectiveness of the FreedomFlow™ Orbital Circumferential Atherectomy System in subjects diagnosed with peripheral arterial disease (PAD) of the lower extremities.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a minimally invasive, catheter-based system designed for improving luminal diameter and modifying vessel wall compliance in patients with PAD.

The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated to remove atherosclerotic plaque and modifying vessel wall compliance within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The objective of the study is to evaluate the safety and effectiveness of the FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel modification in de novo target lesions in the peripheral vasculature of the lower extremities.

Being tested
Orbital Circumferential Atherectomy
Keywords
Peripheral Arterial Diseases, Peripheral Artery Diseases, Arterial Occlusive Diseases, Peripheral Vascular Diseases
Medical subject headings
Peripheral Arterial Disease, Arterial Occlusive Diseases, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orbital Circumferential AtherectomyDevice

    Also called Orbital Atherectomy Atherectomy

    Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

Study groups in NCT03635190
Study groupRoleWhat they receive
InterventionalExperimentalOrbital Circumferential Atherectomy
Receives: Device: Orbital Circumferential Atherectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical Success

    Defined as the ability of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to achieve a residual diameter stenosis ≤50% without adjunctive therapy.

    Measured: At the time of the index procedure, usually within one hour after starting the procedure

  2. Freedom From Major Adverse Events

    Primary safety endpoint is freedom from a composite of new onset major adverse events (MAE) at 30-day follow-up as adjudicated by an Independent Clinical Events Committee. This endpoint is evaluated on a per patient basis.

    Measured: 30 days

Secondary outcomes (7)

  1. Clinical Success

    Defined as the ability of the FreedomFlow™ Orbital Circumferential Atherectomy System to achieve a final diameter stenosis <50% immediately post treatment with or without adjunctive therapy, as assessed by an independent Angiographic Core Laboratory.

    Measured: At index procedure

  2. Procedure Success

    Defined as <50% residual stenosis at target lesion with or without adjunctive therapy, no procedure-related MAE, no device malfunction causing the procedure to be aborted.

    Measured: At index procedure

  3. Ankle Brachia, Index (ABI) Measured at Baseline, 30 Days and 6 Months

    ABI measured at baseline, 30 days and 6 months. ABI ranges from 0 to 1, with smaller values indicating more severe disease. Normal ABI is 1.

    Measured: 30 days and 6 months

  4. Rutherford Classification

    Change in Rutherford Classification at 30 days and 6 months. Rutherford scale ranges from 0 to 6 with higher values indicating more severe disease. Rutherford classifications are: 0 Asymptomatic; 1 Mild Claudication; 2 Moderate Claudication; 3 Severe Claudication; 4 Ischemic Rest Pain; 5 Minor Tissue Loss; 6 Major Tissue Loss.

    Measured: 30 days and 6 months

  5. Vascular Quality of Life Questionnaire (VascuQoL) Administered at Baseline, 30 Days and 6 Months

    Patient reported outcomes (PRO, VascuQoL questionnaire) at baseline, 30 days and 6 months. The VascuQoL questionnaire is a validated PRO for lower limb ischemia patients. The range of scores is 1 (worst) to 7 (best)

    Measured: Baseline, 30 days and 6 months

  6. Target Lesion and Vessel Revascularization

    Clinically driven target lesion revascularization (TLR) at 6 months, target vessel revascularization (TVR) at 30 days and 6 months (as assessed by an independent Angiographic Core Laboratory). Clinically driven target lesion revascularization refers to disease progression that is caused by a recurrence of stenosis at the lesion that was treated; target vessel revascularization refers to disease progression that is caused by a recurrence of stenosis in the same vessel as the treated lesion but at a different site.

    Measured: 30 days and 6 months

  7. Vessel Patency

    Primary patency, primary assisted patency and secondary patency at 30 days and 6 months. Patency will be evaluated on a per lesion basis by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. Restenosis is defined as Peak Systolic Velocity Rate (PSVR) of 2.5. Patency is determined using ultrasound to measure velocity. Patency is indicated for PSVR values < 2.5

    Measured: 30 days and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start17 Dec 2018
  3. Primary completion24 Mar 2021
  4. Study completion13 Oct 2021

Resources

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
Model description
prospective, multi-center, non-randomized single-arm study
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03635190
Sponsor's protocol ID
010-055
Acronym
FASTII
Status last verified
Jul 2022
First submitted
14 Aug 2018
Last updated
4 Nov 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Orbital Circumferential Atherectomy in people with Peripheral Arterial Disease, run by Cardio Flow, Inc. at 13 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 13 inclusion and 22 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 4 Nov 2022). 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?

Technical Success (time frame: At the time of the index procedure, usually within one hour after starting the 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?

On the ClinicalTrials.gov record for NCT03635190.

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 4 Nov 2022.

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