Trials / Completed
CompletedNCT05284240
Prospective, Multi-center, Single-arm Study of the Auryon Laser System for Treatment of Below-the-Knee (BTK) Arteries
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Midwest Cardiovascular Research Foundation · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The Auryon Laser Atherectomy System has been cleared by the FDA to treat infrainguinal arterial disease including in-stent restenosis
Detailed description
To observe the treatment effects of the Auryon Laser Atherectomy System in treating Infrapopliteal peripheral arterial disease
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Auryon Laser System | The Auryon BTK Study is a prospective, single arm multicenter study evaluating the safety and procedural effectiveness of the Auryon laser in treating infrapopliteal disease in patients with critical limb ischemia and claudication. The primary exposure of interest for this study is the use of the AURYON system for atherectomy. |
Timeline
- Start date
- 2022-03-17
- Primary completion
- 2024-09-25
- Completion
- 2024-09-25
- First posted
- 2022-03-17
- Last updated
- 2024-11-21
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05284240. Inclusion in this directory is not an endorsement.