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NCT04229563 · ClinicalTrials.gov registry record
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
A clinical trial, sponsored by Angiodynamics.
- Completed
- Registry status
- 102
- Enrollment target
NCT04229563: Completed study, sponsored by Angiodynamics.
NCT04229563 is a clinical trial that has completed, run by Angiodynamics. The registered enrollment target is 102 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04229563 has completed, sponsored by Angiodynamics.
- COMPLETED
- Registry status
- 102 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage of lesions with successful revascularization of target vessel defined as ≤30% residual stenosis at the treated lesion post Auryon atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.
Interventions
- DEVICE AURYON Atherectomy System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-08-04 |
| Est. Completion | 2023-04-17 |
What the finished NCT04229563 record still lists
NCT04229563 is an observational study that tracks outcomes without assigning an intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which AURYON Atherectomy System is the first listed.
NCT04229563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04229563 about?
NCT04229563 is a clinical study titled "Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease". 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 th...
What is the current status of trial NCT04229563?
This trial is currently completed. The enrollment target is 102 participants. The study started on 2020-08-04. Estimated completion is 2023-04-17.
What interventions are being tested in trial NCT04229563?
The interventions under investigation include: AURYON Atherectomy System (DEVICE).
Who is sponsoring clinical trial NCT04229563?
This trial is sponsored by Angiodynamics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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