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Trial record 1 of 1 for:    03635190
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Evaluation of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease (FASTII)

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ClinicalTrials.gov Identifier: NCT03635190
Recruitment Status : Active, not recruiting
First Posted : August 17, 2018
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
Libra Medical
Information provided by (Responsible Party):
Cardio Flow, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Orbital Circumferential Atherectomy Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, multi-center, non-randomized single-arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional
Orbital Circumferential Atherectomy
Device: Orbital Circumferential 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.
Other Name: Orbital Atherectomy Atherectomy




Primary Outcome Measures :
  1. Technical Success [ Time Frame: At index procedure ]
    Defined as the ability of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to achieve a residual diameter stenosis ≤50% without adjunctive therapy, as assessed by an independent Angiographic Core Laboratory.

  2. Freedom from Major Adverse Events [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Clinical Success [ Time Frame: At index procedure ]
    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.

  2. Procedure Success [ Time Frame: At index procedure ]
    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.

  3. Ankle Brachia, Index (ABI) [ Time Frame: 30 days and 6 months ]
    Change in ABI at 30 days and 6 months.

  4. Rutherford Classification [ Time Frame: 30 days and 6 months ]
    Change in Rutherford Classification at 30 days and 6 months.

  5. Quality of Life questionnaire: VascuQoL [ Time Frame: 30 days and 6 months ]
    Change in patient reported outcomes (PRO, VascuQoL questionnaire) at 30 days and 6 months.

  6. Target Lesion and Vessel Revascularization [ Time Frame: 30 days and 6 months ]
    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).

  7. Vessel Patency [ Time Frame: 30 days and 6 months ]
    Primary patency, primary assisted patency and secondary patency at 30 days and 6 months. Patency will be evaluated by duplex ultrasound and evaluated by an independent Vascular Ultrasound Core Laboratory. The restenosis is defined as PSVR of 2.5.



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

Subjects must meet all of the following criteria to be eligible for participation in the study:

Inclusion Criteria

  1. Age ≥ 18 years old.
  2. Subject is a candidate for percutaneous endovascular intervention for peripheral vascular disease in the lower extremity.
  3. 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.
  4. Clinical presentation of lifestyle limiting claudication, rest pain and/or ischemic wounds as characterized by Rutherford Classification 2, 3, 4, or 5.
  5. Disease is located in the common femoral, superficial femoral, popliteal, tibioperoneal, anterior tibial, posterior tibial, and/or peroneal arteries.

    1. De novo target lesion(s) with stenosis ≥70% by visual estimation and/or
    2. Lesion(s) treated by percutaneous transluminal angioplasty (PTA) and/or atherectomy ≥3 months prior with a restenosis ≥70% by visual estimation.
    3. 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.
  6. Target reference vessel diameter (proximal to and distal to target lesion) is 2 to 8 mm by angiographic visual estimation.
  7. At least one patent vessel run-off to the ankle or foot at baseline.
  8. The target lesion(s) can be successfully crossed with a commercially available 0.014" atherectomy guidewire without any complications during wiring procedure.
  9. 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:

Exclusion Criteria

  1. Is female with childbearing potential not taking adequate contraceptives or is currently breastfeeding.
  2. Target lesion is within a native graft or synthetic graft.
  3. Target lesion is an in-stent restenosis.
  4. 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 IVUS prior to enrollment.
  5. 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.
  6. 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 driveshaft.
  7. Evidence or history of aneurysmal target vessel.
  8. Clinical/angiographic evidence of distal embolization prior to intervention.
  9. 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.
  10. Planned endovascular or surgical procedure prior to the subject's 30 day follow up.
  11. Signs and symptoms of systemic infection (temperature of ≥ 38.0° Celsius and/or 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.
  12. Unstable coronary artery disease or other comorbid condition(s) that, in the judgment of the physician precludes safe percutaneous intervention.
  13. Significant acute or chronic kidney disease with a creatinine level > 2.5mg/dL and/or requiring dialysis.
  14. Evidence of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stoke within 2 months of index procedure.
  15. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  16. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
  17. Heparin-induced thrombocytopenia (HIT) not able to use Bivalirudin.
  18. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2, known coagulopathy, or INR > 1.8.
  19. Evidence of thrombus within target lesion or thrombolytic therapy within 2 weeks of the index procedure.
  20. Has life expectancy < 12 months in the opinion of the investigator.
  21. Subject is unwilling or unable to comply with the follow-up study requirements.
  22. Subject is currently participating in an investigational drug or another investigational device exemption (IDE) study.

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): NCT03635190


Locations
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United States, Florida
Orlando Heart and Vascular Institute
Altamonte Springs, Florida, United States, 32714
Palm Vascular Center of Broward, LLC
Fort Lauderdale, Florida, United States, 33312
Cardiovascular Research of North Florida, LLC
Gainesville, Florida, United States, 32605
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32256
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida, United States, 33410
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Cardiovascular Institute of the South
Opelousas, Louisiana, United States, 70570
United States, Michigan
Advanced Cardiac & Vascular Centers for Amputation Prevention
Grand Rapids, Michigan, United States, 49525
Eastlake Cardiovascular, PC
Saint Clair Shores, Michigan, United States, 48080
United States, Texas
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States, 78756
Texas Tech University Medical Center
Lubbock, Texas, United States, 79430
Orion Medical Research, LLC
Pasadena, Texas, United States, 77505
Cardiovascular Associates of East Texas
Tyler, Texas, United States, 75702
Sponsors and Collaborators
Cardio Flow, Inc.
Libra Medical
Investigators
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Principal Investigator: Fadi Saab, MD Advanced Cardiac & Vascular Amputation Prevention Centers
Principal Investigator: Thomas P Davis, MD Eastlake Cardiovascular
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Responsible Party: Cardio Flow, Inc.
ClinicalTrials.gov Identifier: NCT03635190    
Other Study ID Numbers: 010-055
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Arterial Diseases
Peripheral Artery Diseases
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases