The SELUTION4SFA Trial is a study that looks at ways to treat Peripheral Arterial Disease (PAD), a condition where blood flow is reduced in the arteries. This study compares a special balloon, called the SELUTION SLR™ 018 DEB, with a regular balloon during a procedure to open blocked arteries in the leg. The study will include up to 300 people from the US, Europe, and Asia.
Participants will be randomly divided into two groups: one will receive treatment with the special SELUTION balloon, and the other with a regular balloon. Some participants may also join a smaller sub-study to learn how the special balloon interacts with the body. The study is closely monitored, and participants must meet certain health criteria to join.
- Study involves random assignment to one of two treatment groups.
- Participants may need to attend multiple study visits for evaluations and follow-ups.
- Eligibility includes being over 18 and having specific artery conditions.
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