1. Documented PAD with Rutherford classification 2 - 4; and
2. De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries.
You may not be if
1. Less than 18 years old;
2. Inability or refusal to give informed consent by the patient or legally authorized representative;
3. Life expectancy ≤ 12 months, per investigator assessment;
4. Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure;
5. Unable or unwilling to comply with the follow-up schedule; or
6. Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.
Clareo Health | EVERO Drug-coated Balloon (DCB) Randomized Trial
