Percutaneous Coronary Intervention (PCI) Clinical Trials

• Subject must be at least 18 years of age.

• Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.

• Subject is eligible for percutaneous coronary intervention (PCI).

• Subject is willing to comply with all protocol-required follow-up evaluation.

• Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.

• Target lesion is a de novo lesion located in a native coronary artery.

• Target lesion must have visually estimated stenosis \> 50% and \< 100% in symptomatic subjects (\>70% and \<100% in asymptomatic subjects) prior to lesion pre-dilation.

• Target lesion must be successfully pre-dilated.

• If a non-target lesion is treated, it must be treated first and must be deemed a success.