NCT04010045

REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study

REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Ra Medical Systems · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.

Detailed description

This is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease. This study covers the use of endovascular devices including the DABRA Laser System and other devices commercially used in the United States for the treatment of lower extremity PAD.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Endovascular Treatment of PAD	PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.

Timeline

• Start date: 2019-05-02
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2019-07-08
• Last updated: 2021-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study