The Valentines Trial

Inclusion Criteria:

• Patients, male or female, > 18 years of age;
• Patients who present with in-stent restenosis of a previously placed stent documented by coronary angiogram for which re-PCI is planned;
• The patient has stable or unstable angina, and/or clinical evidence of ischemia (ECG, exercise test, etc.);
• The target lesion is in a native vessel;
• Up to two lesions per patient;
• Target lesion(s) stenosis is > 50%.

Exclusion Criteria:

• The patient has had an acute myocardial infarction within the last 48 hours;
• The patient has a co-morbid illness (i.e. any illness likely to limit his/her life expectancy to <12 months);
• Lesion(s) requiring additional stenting either bare metal or drug eluting (non, bail-out indications);
• The patient has had previous therapeutic radiation to the target vessel;
• The patient is unable the take dual antiplatelet therapy for at least 6 months;
• Patients with three or more lesions with in-stent restenosis requiring angioplasty.