The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
376
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
DCB angioplasty with any commercially available drug-coated balloon
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
RECRUITINGElisabeth-Krankenhaus Essen GmbH
Essen, Germany
RECRUITINGUniversitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGDeutsches Herzzentrum München
Munich, Germany
RECRUITINGHospital Universitario de La Princesa Madrid
Madrid, Madrid, Spain
RECRUITINGComposite endpoint of major adverse cardiac event (MACE)
Composite endpoint of major adverse cardiac event (MACE) * all-cause death * myocardial infarction * target lesion revascularization (TLR)
Time frame: 24 months of clinical follow-up after randomization
Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR
Time frame: 24 months of clinical follow-up after randomization
Individual endpoints of the composite endpoints
* all-cause death * myocardial infarction * target lesion revascularization (TLR)
Time frame: 24 months of clinical follow-up after randomization
Stent thrombosis according to the ARC criteria
Time frame: 24 months of clinical follow-up after randomization
Safety endpoint: a composite endpoint of all-cause death and myocardial infarction
Time frame: 24 months of clinical follow-up after randomization
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