An interventional study of Atherectomy in Peripheral Arterial Disease, sponsored by Ra Medical Systems. Completed at 10 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by Ra Medical Systems · Not applicable, Interventional, and Treatment
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 108 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Ra Medical Systems is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants must meet all of the inclusion criteria to participate in this study:
Inclusion Criteria
Angiographic Inclusion Criteria
Participants meeting any of the exclusion criteria at the time of enrollment (index procedure/ intervention) will be excluded from study participation:
Exclusion Criteria
Device: DABRA Laser System Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System.
Device: Atherectomy
Endovascular treatment of peripheral arterial disease
Also known as: DABRA Laser System
Technical Success
The Primary Efficacy Endpoint is the mean reduction in percent diameter stenosis in each subject's primary lesion following treatment with the DABRA Laser System and before any other treatment, as assessed by an independent Angiographic Core Laboratory.
Time frame: At Index Procedure
Freedom from Major Adverse Events (MAE)
Primary safety endpoint is freedom from Major Adverse Events, defined as all-cause mortality, unplanned major target limb amputation (at or above the ankle), clinically driven target limb revascularization (CD-TLR) at 30 Days, as classified by the Clinical Events Committee (CEC).
Time frame: 30 Days
Incidence of Target Lesion Revascularization (TLR) at 6 months
Clinically driven target lesion revascularization (TLR) at 6 months.
Time frame: 6 months
Reduction in Residual Diameter Stenosis
Incidence of achieving a residual diameter percent stenosis of ≤ 50% in the primary lesion on the day of treatment, prior to any adjunctive therapy.
Time frame: At Index Procedure
Rutherford Classification
Change from baseline in Rutherford Category.
Time frame: 30 Days, 6 Months
Change in Percent Diameter Stenosis
Percent diameter stenosis and change from baseline in percent diameter stenosis as measured by Doppler Ultrasound and assessed by an independent core laboratory.
Time frame: 30 Days, 6 Months
Vessel Patency
Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.
Time frame: 30 Days, 6 Months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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