At a glance
ClinicalIndex Comparison RecordN/ACompleted· 102 enrolled
Drug / intervention
AURYON Atherectomy Systemdevice
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.
PATHFINDER Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (EX-PAD-05)
In Brief
An observational study evaluating AURYON Atherectomy System for Infrainguinal Peripheral Artery Disease and 2 related conditions. Completed, enrolled 102 participants across 10 sites.
Detailed Summary
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON Atherectomy System, within the initial launch phase of the product in the market.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartAug 2020
Primary CompletionMar 2021
Study CompletionApr 2023
TodayJul 2026
First PostedJan 18, 2020
Enrollment StartAug 4, 2020
Primary CompletionMar 17, 2021
Study CompletionApr 17, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.5 years ago
Interventions
AURYON Atherectomy Systemdevice
The AURYON Atherectomy System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.