NCT02653456

Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease

A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Ra Medical Systems · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.

Detailed description

The study is a multi center, prospective, non-randomized, open-label study conducted at a minimum of one investigational center. 50 subjects can be enrolled. Follow-up occurs at the end of the procedure in the form of an angiogram to determine if the lesion was crossed. Additional follow-up may not necessary because of the binary nature of the crossing, and also because any future follow-up would be assessing the effectiveness of adjunct therapy, e.g. balloon angioplasty. Long term results are entirely dependent on this subsequent treatment. Because the DABRA crosser only allows adjunct devices to be used, 30-day follow-up measuring the performance of the adjunct therapy might affect the physician's choice of therapy, and compromise the patient's treatment. Therefore, 30-day follow-up, which evaluates the effectiveness of the adjunct therapy, might raise ethical concerns. However, the follow-up can be done by Ankle-Brachial Index, Doppler ultrasound, auscultation, or by discussion of the level of claudication and motion pain with the patient. To evaluate the safety and efficacy of the RA-308 Excimer Laser System and DABRA Catheter for treating subjects with symptomatic infrainguinal lower extremity vascular disease with chronic total occlusions that cannot be crossed with standard guide wires, or lesions where an attempt to cross would, in the opinion of the interventionalist, result in either a subintimal path or a perforation.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	RA-308 Excimer Laser and DABRA Catheter	See information already included in arm description

Timeline

• Start date: 2016-04-07
• Primary completion: 2017-05-03
• Completion: 2017-07-14
• First posted: 2016-01-12
• Last updated: 2018-11-21
• Results posted: 2018-10-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study