Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD) (FAST)

• ClinicalTrials.gov Identifier: NCT03365154
• Recruitment Status: Completed
• First Posted: December 7, 2017
• Results First Posted: May 20, 2021
• Last Update Posted: May 20, 2021
• Sponsor: Cardio Flow, Inc.
• Collaborator: Libra Medical
• Information provided by (Responsible Party): Cardio Flow, Inc.

Study Description

Brief 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. 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,

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Device: Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment; Device: Balloon Angioplasty	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease
• Actual Study Start Date: January 25, 2018
• Actual Primary Completion Date: February 22, 2018
• Actual Study Completion Date: November 6, 2018

Arms and Interventions

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.	Device: Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment; Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.; Other Name: Orbital Atherectomy Treatment; Device: Balloon Angioplasty; Low pressure balloon angioplasty may be used following atherectomy

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.

Secondary Outcome Measures :

1. Serious Adverse Events [ Time Frame: Through six months ]
   All device and procedure related Serious Adverse Events at 30 days and 6 months
2. Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy [ Time Frame: At time of procedure ]
   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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Cardiovascular Research of North Florida, LLC

Gainesville, Florida, United States, 32605

United States, Michigan

Eastlake Cardiovascular, PC

Saint Clair Shores, Michigan, United States, 48080

Sponsors and Collaborators

Cardio Flow, Inc.

Libra Medical

Investigators

• Study Director: Phil Zang, MD; Libra Medical

  Study Documents (Full-Text)

Documents provided by Cardio Flow, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] November 20, 2017

Informed Consent Form  [PDF] December 5, 2017

More Information

• Responsible Party: Cardio Flow, Inc.
• ClinicalTrials.gov Identifier: NCT03365154
• Other Study ID Numbers: 010-031
• First Posted: December 7, 2017
• Results First Posted: May 20, 2021
• Last Update Posted: May 20, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Descriptive statistics of primary and secondary endpoints may be shared.

• 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 Artery Disease; Atherectomy; Orbital Atherectomy

Additional relevant MeSH terms:

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