The Valentines Trial

The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse cardiac events (MACE: death, myocardial infarction [MI], target lesion revascularization [TLR]) and target vessel revascularization [TVR]) and stent thrombosis, both early and late occurrences will be assessed.

In addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel eluting balloon treatment for in-stent restenosis.

A prioi analysis will be comparison of the safety and efficacy of patients presenting with drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.

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.