To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Endovascular treatment of peripheral arterial disease
California Heart & Vascular Clinic
El Centro, California, United States
Merced Vein & Vascular Center
Merced, California, United States
The Cardiac & Vascular Institute
Gainesville, Florida, United States
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
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Vascardio Heart and Vascular Institute
Hialeah, Florida, United States
MIMIT Health
Chicago, Illinois, United States
MIMIT Health
Glen Ellyn, Illinois, United States
Eastlake Cardiovascular
Roseville, Michigan, United States
South Texas Vascular Institute
Edinburg, Texas, United States
Texas Tech University Health Sciences Center - Center for Cardiovascular Health
Lubbock, Texas, United States
Laser Surgical Solutions
McAllen, Texas, United States
Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.
Time frame: 30 Days, 6 Months