Impact of drug-coating balloon on in-stent restenosis compared with conventional treatment: a prospective multicenter OCT registry
Not Applicable
Recruiting
- Conditions
- in-stent restenosis
- Registration Number
- JPRN-UMIN000017960
- Lead Sponsor
- Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in % Area Stenosis and late lumen loss assessed by OCT
- Secondary Outcome Measures
Name Time Method (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