REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study

Study Overview
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Brief Summary
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This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.

Detailed Description
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This is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease. This study covers the use of endovascular devices including the DABRA Laser System and other devices commercially used in the United States for the treatment of lower extremity PAD.

Official Title
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REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Endovascular Treatment of PAD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant's age ≥ 22 years. Participant presents with a Rutherford category of 2 to 6. Participant has at least one peripheral lesion, ≤ 140mm, in a native vessel that is treated successfully with DABRA Laser System. Participant is able and willing to be anti-coagulated. Ability and willingness of participant to give written informed consent and comply with follow-up. Exclusion Criteria: 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. Endovascular interventions within 90 days prior to study enrollment (on leg to be treated). Participation in another cardiovascular or peripheral vascular study that might, in the judgement of the Investigator, affect the results of the study. Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast. Inability or unwillingness of the patient to comply with study examinations. Necrosis necessitating major amputation. Subject has an anticipated life span of less than one (1) year. Medically non-compliant subjects, based on Investigator judgment (e.g., subject is non-compliant in following medical advice regarding blood pressure medication, cholesterol medication, and/or maintenance of healthy blood sugar levels). No run-off vessel is present when treating above the knee. A run-off vessel is required when treating above the knee, however, it is not required when treating below the knee.

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endovascular Treatment of PAD|PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel Patency | Patency of the target lesion at 24 months, as determined by duplex ultrasound. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Tabulation of serious adverse events at 1 day, 6 months, 12 months, 18 months, and 24 months | 1 day, 6 months, 12 months, 18 months, and 24 months | 
| Vessel Patency | Patency of the target lesion at 6 months, 12 months, and 18 months, as determined by duplex ultrasound. | 6 months, 12 months, and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower extremity PAD