A prospective, open-label, single-centre, randomized study to evaluate coronary microcirculation in de-novo lesions treated with drug-coated balloons or drug-eluting stents
Not Applicable
Recruiting
- Conditions
- Coronary artery disease
- Registration Number
- JPRN-UMIN000052443
- Lead Sponsor
- Other
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
(1) left ventricular ejection fraction <30% (2) known renal failure (creatinine >2mg/dl) (3) acute myocardial infarction within the previous 48 hours (4) history of severe valvular heart disease or hypertrophic cardiomyopathy (5) previous intervention to the same vessel (6) life expectancy <1 year (7) inappropriate lesion for assessment of microcirculation (i.e., left main lesions, ostial lesions, heavily calcified lesions, thrombotic lesions)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The status of the coronary microcirculation before and after treatment and at follow-up angiography
- Secondary Outcome Measures
Name Time Method Indices of Coronary Physiology before and after treatment and at follow-up angiography Restenosis and late lumen loss at follow-up angiography Major adverse cardiac events (all-cause death, myocardial infarction and target lesion revascularization) Canadian Cardiovascular Society grading of angina pectoris after treatmen