At a glance
ClinicalIndex Comparison RecordN/ACompleted· 112 enrolled
Drug / intervention
Orbital Circumferential Atherectomydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System to Treat Peripheral Artery Disease
In Brief
A clinical study evaluating Orbital Circumferential Atherectomy for Peripheral Arterial Disease. Completed, enrolled 112 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Arterial Disease
CountriesUnited States
CollaboratorsLibra Medical
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartDec 2018
Primary CompletionMar 2021
Study CompletionOct 2021
TodayJul 2026
First PostedAug 17, 2018
Enrollment StartDec 17, 2018
Primary CompletionMar 24, 2021
Study CompletionOct 13, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.9 years ago
Interventions
Orbital Circumferential Atherectomydevice
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.