Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER I)
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|ClinicalTrials.gov Identifier: NCT04229563|
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment|
|Infrainguinal Peripheral Artery Disease||Device: AURYON™ System|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||PATHFINDER I: Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER-Registry, EX-PAD-05)|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||August 2023|
Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
Device: AURYON™ System
The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.
- Primary Efficacy: Acute Procedural Success [ Time Frame: Through discharge, an average of 8 weeks ]Percentage of subjects with successful revascularization of target vessel defined as ≤30% residual stenosis at the index lesion post AURYON™ atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229563
|Contact: Alicia Conwayemail@example.com|