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

NCT03365154 | Completed Results FDA Device

• 1 other identifier: 010-031
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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,

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Artery Disease; Atherectomy; Orbital Atherectomy

Outcome Measures

Primary Outcomes (2)

• 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

  At time of procedure

• 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.

  30 days

Secondary Outcomes (2)

• Serious Adverse Events

  Through six months

• Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy

  At time of procedure

Study Arms (1)

Treatment Group

EXPERIMENTAL

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; Device: Balloon Angioplasty

Interventions

Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment DEVICE

Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.

Also known as: Orbital Atherectomy Treatment

Treatment Group

Balloon Angioplasty DEVICE

Low pressure balloon angioplasty may be used following atherectomy

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cardio Flow, Inc.: lead
• Libra Medical: collaborator

Study Sites (2)

Cardiovascular Research of North Florida, LLC

Gainesville, Florida, 32605, United States

Location

Eastlake Cardiovascular, PC

Saint Clair Shores, Michigan, 48080, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Phil Zhang, MD
• Organization: Libra Medical

pzhang@libramed.com

6692039308

Study Officials

• Phil Zang, MD

  Libra Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 7, 2017
• Study Start: January 25, 2018
• Primary Completion: February 22, 2018
• Study Completion: November 6, 2018
• Last Updated: May 20, 2021
• Results First Posted: May 20, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)