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NCT05284240 · ClinicalTrials.gov registry record · NA
Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries
A NA study, sponsored by Midwest Cardiovascular Research Foundation.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT05284240: Completed NA study, sponsored by Midwest Cardiovascular Research Foundation.
NCT05284240 is a NA study that has completed, run by Midwest Cardiovascular Research Foundation. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05284240, a NA study, has completed, sponsored by Midwest Cardiovascular Research Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis
Primary Outcome
Major Adverse Limb Events (MALE) + Post-Operative Death (POD) at 30 days, as adjudicated by the CEC, defined as a composite of: 1. All-cause death 2. Above-ankle amputation of the index limb 3. Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a BTK artery
Interventions
- DEVICE Auryon Laser System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-03-17 |
| Est. Completion | 2024-09-25 |
| Phase | NA |
What the finished NCT05284240 record still lists
NCT05284240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Auryon Laser System is the first listed.
NCT05284240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05284240 about?
NCT05284240 is a clinical study titled "Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries". The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis
What is the current status of trial NCT05284240?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2022-03-17. Estimated completion is 2024-09-25.
What interventions are being tested in trial NCT05284240?
The interventions under investigation include: Auryon Laser System (DEVICE).
Who is sponsoring clinical trial NCT05284240?
This trial is sponsored by Midwest Cardiovascular Research Foundation, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05284240's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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