Trials / Completed
CompletedNCT03157531
Safety and Effectiveness of B-Laser™ in Subjects Affected With Infrainguinal PAD
Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™ Atherectomy Device, in Subjects Affected With Infrainguinal PAD
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- Eximo Medical Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single-arm, multi-center, international, open-label, clinical study.
Detailed description
The aim of the study is to assess the safety and efficacy of the Eximo Medical's B-Laser™ Atherectomy catheter in subjects with infrainguinal Peripheral Artery Disease (PAD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | B-Laser™ Atherectomy System | The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses |
Timeline
- Start date
- 2017-09-06
- Primary completion
- 2018-04-27
- Completion
- 2018-10-11
- First posted
- 2017-05-17
- Last updated
- 2019-06-20
- Results posted
- 2019-06-20
Locations
11 sites across 3 countries: United States, Austria, Italy
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03157531. Inclusion in this directory is not an endorsement.