N/A N=10 Treatment

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

Peripheral Arterial Disease

Bottom Line

View on ClinicalTrials.gov: NCT03365154 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

May 2021

Primary outcome: Primary: Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy — 3 lesion

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment (Device); Balloon Angioplasty (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cardio Flow, Inc.
Primary completion: Feb 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Treated Lesions With Achievement of ≤ 50% Residual Stenosis Without Adjunctive Therapy	3	—
PRIMARY Number of Participants Who Were Free From New-onset Major Adverse Events at 30 Days Post-treatment	10	—
SECONDARY Serious Adverse Events	—	—
SECONDARY Number of Lesions With Achievement of ≤ 50% Residual Stenosis With or Without Adjunctive Low-pressure Balloon Therapy	11	—

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,

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03365154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.