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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment
Balloon Angioplasty
Sponsored by
Cardio Flow, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Artery Disease, Atherectomy, Orbital Atherectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiovascular Research of North Florida, LLC
  • Eastlake Cardiovascular, PC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Patients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Serious Adverse Events
All device and procedure related Serious Adverse Events at 30 days and 6 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.

Full Information

First Posted
December 1, 2017
Last Updated
April 29, 2021
Sponsor
Cardio Flow, Inc.
Collaborators
Libra Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03365154
Brief Title
Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat Peripheral Artery Disease (PAD)
Acronym
FAST
Official Title
Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
February 22, 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardio Flow, Inc.
Collaborators
Libra Medical

4. Oversight

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
Data Monitoring Committee
No

5. 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,
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral Artery Disease, Atherectomy, Orbital Atherectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Patients with occlusive arterial disease who meet the study criteria and provide informed consent will receive atherectomy treatment with the investigational device.
Intervention Type
Device
Intervention Name(s)
Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment
Other Intervention Name(s)
Orbital Atherectomy Treatment
Intervention Description
Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.
Intervention Type
Device
Intervention Name(s)
Balloon Angioplasty
Intervention Description
Low pressure balloon angioplasty may be used following atherectomy
Primary Outcome Measure Information:
Title
Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy
Description
Achievement of ≤ 50% residual stenosis without adjunctive therapy as assessed angiographically on a per lesion basis
Time Frame
At time of procedure
Title
Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Serious Adverse Events
Description
All device and procedure related Serious Adverse Events at 30 days and 6 months
Time Frame
Through six months
Title
Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy
Description
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.
Time Frame
At time of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phil Zang, MD
Organizational Affiliation
Libra Medical
Official's Role
Study Director
Facility Information:
Facility Name
Cardiovascular Research of North Florida, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Eastlake Cardiovascular, PC
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48080
Country
United States

12. IPD Sharing Statement

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

Learn more about this trial

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

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