The 001 DIOR study is a prospective, multicenter registry of percutaneous coronary intervention (PCI) to assess the clinical success, efficacy and safety of the Paclitaxel-eluting balloon DIOR (Eurocor GmbH, Germany) for the treatment of de novo ostial bifurcated lesions (001 of Medina classification). The DIOR balloon will be used to treat the stenotic site branch.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)
Hospital del Mar
Barcelona, Spain
Hospital Sant Pau
Barcelona, Spain
Hospital Trías i Pujol
Barcelona, Spain
Major adverse cardiac events (MACE)
MACE rate defined as the rate of cardiac death and/or myocardial infarction (MI) and/or target lesion revascularization (TLR)
Time frame: 6 months
target vessel revascularization (TVR) rate, either symptom or ischemia-driven
Time frame: 6 months
Segment treated thrombosis (STT), according to ARC definitions
Time frame: 6 months
Late Lumen Loss
Late lumen loss determinated by control angiography
Time frame: 6 months
Binary restenosis rate
Time frame: 6 months
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