A Prospective, Multicenter, Randomized Trial of New Cutting Balloon Versus Conventional Balloon for the Treatment of Severe Calcified Lesio
- Conditions
- Ischemic heart diseasecoronary artery disease
- Registration Number
- JPRN-jRCTs052200044
- Lead Sponsor
- Koyama Kohei
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 170
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.
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%;
x) Severe valvular disease; or
xi) Severe renal impairment (eGFR < 30mL/min/1.72m2, under non-dialysis).
2) Pregnant or lactating women
3) Patients with a history of hypersensitivity to contrast medium
4) Patients with a life expectancy of less than one year
5) Other patients determined to be ineligible for inclusion in the trial by the principal investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method