Trial Outcomes & Findings for Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease (NCT NCT02653456)

NCT ID: NCT02653456

Last Updated: 2018-11-21

Results Overview

Crossing the target lesion based on angiographic analysis

Recruitment status

COMPLETED

Study phase

Target enrollment

64 participants

Primary outcome timeframe

at time of procedure

Results posted on

2018-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	RA-308 Excimer Laser and DABRA Catheter Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Overall Study STARTED	64
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RA-308 Excimer Laser and DABRA Catheter n=64 Participants Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. The catheter and laser are a system, and cannot be used separately. RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description
Age, Continuous	72 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	64 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants
Region of Enrollment Mexico	15 participants n=5 Participants
Chronic total occlusion	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: at time of procedure

Crossing the target lesion based on angiographic analysis

Outcome measures

Outcome measures
Measure	RA-308 Excimer Laser and DABRA Catheter n=64 Participants Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. The catheter and laser are a system, and cannot be used separately. RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description
Crossing the Target Lesion	60 Participants

SECONDARY outcome

Timeframe: at time of procedure, up to an hour

Number of participants with no device-related major adverse events as determined by physician evaluation

Outcome measures

Outcome measures
Measure	RA-308 Excimer Laser and DABRA Catheter n=64 Participants Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. The catheter and laser are a system, and cannot be used separately. RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description
Number of Participants With no Device-related Major Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participants with target lesion revascularization as determined by physician evaluation

Outcome measures

Outcome measures
Measure	RA-308 Excimer Laser and DABRA Catheter n=59 Participants Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. The catheter and laser are a system, and cannot be used separately. RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description
Number of Participants With Target Lesion Revascularization	0 Participants

SECONDARY outcome

Timeframe: 6 months

Number of participants with target lesion revascularization as determined by physician evaluation

Outcome measures

Outcome measures
Measure	RA-308 Excimer Laser and DABRA Catheter n=38 Participants Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. The catheter and laser are a system, and cannot be used separately. RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description
Number of Participants With Target Lesion Revascularization	0 Participants

Adverse Events

RA-308 Excimer Laser and DABRA Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President of Regulatory Affairs and Quality Assurance

Ra Medical Systems, Inc.

Phone: 877-635-1800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place