Peripheral Arterial Disease
Conditions
Keywords
lower extremity Peripheral Arterial Disease (PAD)
Brief summary
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
Interventions
DEVICEAtherectomy
Endovascular treatment of peripheral arterial disease
Sponsors
Ra Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the inclusion criteria to participate in this study: Inclusion Criteria 1. Ability and willingness to give written informed consent and comply with follow-up requirements 2. PAD with Rutherford Class 2-5 3. Stenotic lesion(s) in the peripheral vasculature 4. Subject is a candidate for atherectomy for infrainguinal peripheral artery disease Angiographic Inclusion Criteria 1. Target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by Investigator) 2. Target vessel ≤ 3.0 mm in diameter 3. Target Lesion ≤ 25cm in length 4. The lesion to be treated is not severely calcified 5. Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access 6. No use of another atherectomy device in the same procedure 7. Treatment site is not located in a graft 8. Treatment site is not in, or distal to, a previously placed stent 9. No flow limiting dissection proximal, distal, or in the target lesion (prior to the use of the investigational device) Participants meeting any of the
Exclusion criteria
at the time of enrollment (index procedure/ intervention) will be excluded from study participation:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | At Index Procedure | 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. |
| Freedom from Major Adverse Events (MAE) | 30 Days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vessel Patency | 30 Days, 6 Months | Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory. |
| Rutherford Classification | 30 Days, 6 Months | Change from baseline in Rutherford Category. |
| Reduction in Residual Diameter Stenosis | At Index Procedure | Incidence of achieving a residual diameter percent stenosis of ≤ 50% in the primary lesion on the day of treatment, prior to any adjunctive therapy. |
| Incidence of Target Lesion Revascularization (TLR) at 6 months | 6 months | Clinically driven target lesion revascularization (TLR) at 6 months. |
| Change in Percent Diameter Stenosis | 30 Days, 6 Months | Percent diameter stenosis and change from baseline in percent diameter stenosis as measured by Doppler Ultrasound and assessed by an independent core laboratory. |
Countries
United States
Outcome results
None listed