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

• ClinicalTrials.gov Identifier: NCT03635190
• Recruitment Status: Completed
• First Posted: August 17, 2018
• Results First Posted: November 4, 2022
• Last Update Posted: November 4, 2022
• Sponsor: Cardio Flow, Inc.
• Collaborator: Libra Medical
• Information provided by (Responsible Party): Cardio Flow, Inc.

Study Description

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 (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.

Study Design

• 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
• Actual Primary Completion Date: March 24, 2021
• Actual Study Completion Date: October 13, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Technical Success [ Time Frame: At the time of the index procedure, usually within one hour after starting the procedure ]
   Defined as the ability of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to achieve a residual diameter stenosis ≤50% without adjunctive therapy.
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. This endpoint is evaluated on a per patient basis.

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) Measured at Baseline, 30 Days and 6 Months [ Time Frame: 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.
4. Rutherford Classification [ Time Frame: 30 days and 6 months ]
   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.
5. Vascular Quality of Life Questionnaire (VascuQoL) Administered at Baseline, 30 Days and 6 Months [ Time Frame: 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)
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). 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.
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 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

Eligibility Criteria

• 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 Intra-vascular ultrasound (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 drive shaft.
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 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.
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 international normalized ratio (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.

Contacts and Locations

Locations

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

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

• Principal Investigator: Fadi Saab, MD; Advanced Cardiac & Vascular Amputation Prevention Centers
• Principal Investigator: Thomas P Davis, MD; Eastlake Cardiovascular

  Study Documents (Full-Text)

Documents provided by Cardio Flow, Inc.:

Study Protocol  [PDF] April 2, 2020

Statistical Analysis Plan  [PDF] February 4, 2020

More Information

• Responsible Party: Cardio Flow, Inc.
• ClinicalTrials.gov Identifier: NCT03635190
• Other Study ID Numbers: 010-055
• First Posted: August 17, 2018
• Results First Posted: November 4, 2022
• Last Update Posted: November 4, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases