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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Valentines Trial|
- Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis [ Time Frame: 6-9 month ] [ Designated as safety issue: Yes ]
- In-stent and in-segment late loss and binary restenosis [ Time Frame: 6-9 month ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066832
|Heart Center Munich at the Isar|
|Principal Investigator:||Pieter Stella, MD, PhD||UMC Utrecht, Utrecht, Netherlands|
|Principal Investigator:||Sigmund Silber, Prof.||Heart Center Munich at the Isar, Munich, Germany|
|Principal Investigator:||Giuseppe Sangiorgi, MD||Policlinico Modena, Modena, Italy|