NCT02556255

Safety and Effectiveness Study of Eximo's B-Laser™ Atherectomy Device for PAD Treatment

Safety and Effectiveness Evaluation of Eximo's B-Laser™ Atherectomy Device, in Subjects Affected With PAD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Eximo Medical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess the safety and efficacy of the use of the Eximo's B-Laser™ catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity arteries.

Detailed description

This is a prospective, single-arm, multi-center, international, open-label, non-randomized clinical study. All enrolled subjects will undergo atherectomy procedure, during which the B-Laser™ catheter will be used to perform atherectomy in target lesion, followed by any other adjunctive therapy (balloon and/or stent etc.). The procedure will be done according to standard hospital procedure for atherectomy. The steps of the operation before and after the operating of the B-Laser™ device are routinely used practice and will be done according to local practice at each hospital. For the post-atherectomy stage, as an adjunctive therapy in the procedure, any approved device may be used (balloon and/or stent etc.). Subjects will then be followed for 12 months after the procedure.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	B-Laser™ Atherectomy Catheter	Laser atherectomy catheter based on 355 nm

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-08-01
• Completion: 2020-11-20
• First posted: 2015-09-22
• Last updated: 2021-03-03
• Results posted: 2019-02-21

Locations

2 sites across 1 country: Poland