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PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and popliteal arteries. The trial will enroll up to 15 subjects.
Full description
PREVEIL will enroll patients presenting with angiographic evidence of significant stenosis in the femoral or popliteal arteries. All enrolled subjects will be treated with the SurVeil DCB.
Enrollment
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Inclusion criteria
Subjects must meet all of the following criteria to participate in the trial:
Exclusion criteria
Subjects will be excluded from the trial if any of the following criteria are met:
Primary purpose
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Interventional model
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13 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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