JPRN-jRCTs052200044
Recruiting
未知
A Prospective, Multicenter, Randomized Trial of New Cutting Balloon Versus Conventional Balloon for the Treatment of Severe Calcified Lesion - PREDICTION study
Koyama Kohei0 sites170 target enrollmentAugust 20, 2020
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Ischemic heart disease
- Sponsor
- Koyama Kohei
- Enrollment
- 170
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Among patients with ischemic heart disease scheduled to receive coronary artery intervention for heavily calcified lesion found on coronary angiography conducted before inclusion in this trial, those who meet all of the following inclusion criteria and none of the exclusion criteria are considered to be eligible:
- •1\) Patients who gave written consent to participate in the study; and
- •2\) Patients aged 20 years or older when giving informed consent.
Exclusion Criteria
- •1\) Patients with any of the following:
- •i) Lesion in the left main trunk;
- •ii) ST\-elevation acute myocardial infarction (within 24 hours from onset);
- •iii) Lesion in bypass graft;
- •iv) In\-stent restenotic lesion;
- •v) Chronic total occlusion lesion;
- •vi) Cardiogenic shock (systolic blood pressure \< 90 mmHg sustained for 10 minutes or longer with no support, e.g. intra\-aortic balloon pumping);
- •vii) Acute\-phase cardiac failure;
- •viii) Sustained ventricular arrhythmia;
- •ix) Ejection Fraction \< 30%;
Outcomes
Primary Outcomes
Not specified
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