NCT01066832

The Valentines Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Eurocor GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Instent Restenosis

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel-coated balloon (3 µg/mm2)

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2010-02-10
• Last updated: 2011-06-17

Locations

3 sites across 3 countries: Germany, Italy, Netherlands