in-stent restenosis
Conditions
Interventions
Drug-coating balloon
Conventional treatment (POBA or Drug elutiing stent)
Sponsors
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following conditions will be included: 1)in-stent restenosis (% stenosis >50% assessed by CAG) 2)between 20 and 85 years old 3)written consent for participation in the study 4)tolerance of dual antiplatelet therapy
Exclusion criteria
Exclusion criteria: Patients meeting one of the following conditions will be excluded: 1) Left main trunk lesion 2) severe heart failure (NYHA/New York Heart Association stage III or severer)severe liver dysfunction 3) malignancies or other diseases with poor prognosis 4) renal dysfunction (>Cre 2.0mg/dL) 5) past medical history of hypersensitivity to investigational drugs 6) pregnant, lactating, and possibly pregnant women and those planning to become pregnant 7) indication of rotablator or ELCA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in % Area Stenosis and late lumen loss assessed by OCT | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)late lumen loss = minimal lumen diameter post PCI - minimal lumen diameter at 6-month follow-up by QCA (2)OCT assessment of the patern of neointimal proliferlation at in-stent restenosis (3)MACE(TLR, MI, cardiac death) at 1 year follow-up | — |
Countries
Japan
Contacts
Public ContactMasaru Kuroda
Kobe University Graduate School of Medicine Division of Cardiovascular Medicine
Outcome results
None listed