A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.

Official Title
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A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Atherectomy


Participation Criteria
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Eligibility Criteria
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Participants must meet all of the inclusion criteria to participate in this study: Inclusion Criteria Ability and willingness to give written informed consent and comply with follow-up requirements PAD with Rutherford Class 2-5 Stenotic lesion(s) in the peripheral vasculature Subject is a candidate for atherectomy for infrainguinal peripheral artery disease Angiographic Inclusion Criteria Target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by Investigator) Target vessel ≤ 3.0 mm in diameter Target Lesion ≤ 25cm in length The lesion to be treated is not severely calcified Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access No use of another atherectomy device in the same procedure Treatment site is not located in a graft Treatment site is not in, or distal to, a previously placed stent 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: Exclusion Criteria Age below 22 years Pregnant, breastfeeding, planning to become pregnant. If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately. Myocardial infarction (MI) ≤ 60 days prior to procedure Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated Life expectancy ≤ 12 months Patient is participating in another investigational drug or device study

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Excimer Laser Photoablation<br>Device: DABRA Laser System Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System. | Device: Atherectomy<br>* Endovascular treatment of peripheral arterial disease<br>* Other names: DABRA Laser System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Target Lesion Revascularization (TLR) at 6 months | Clinically driven target lesion revascularization (TLR) at 6 months. | 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. | At Index Procedure | 
| Rutherford Classification | Change from baseline in Rutherford Category. | 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. | 30 Days, 6 Months | 
| Vessel Patency | Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory. | 30 Days, 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower extremity Peripheral Arterial Disease (PAD)