Protocol
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M.G. male, 62y
Before: focal 70% DES in-stent restenosis
FUP: open RCA, good result 6 months post-Dior balloon dilatation of the DES in-stent restenosis
Study Title:
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 (as defined by the ARC definite and probable definitions).
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.