Ischemic heart disease coronary artery disease
Conditions
Interventions
In order to align baseline characteristics of patients, subjects will be randomly allocated to each group at a ratio of 1:1 using a stratified permuted block method. The block size and other details o
Sponsors
Koyama Kohei
Eligibility
Sex/Gender
All
Inclusion 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: Inclusion criteria: 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
Exclusion criteria: 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%; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum stent area (MSA) | — |
Secondary
| Measure | Time frame |
|---|---|
| i) Final mean lumen area (mean lumen area = lumen volume/stent length), ii) Minimum lumen area (MLA), iii) Stent dilatation ratio (MSA/average reference area), iv) Presence/absence of breaking point and fracture of coronary artery calcification after pre-dilation, v) Final TIMI (Thrombolysis in Myocardial Infarction) flow grade,PCI-related myocardial infarction, vi) MSA at 9 months after treatment, vii) Target lesion revascularization, viii) Target blood vessel revascularization, ix) LCBI (Lipid core burden index) | — |
Contacts
Public ContactKohei Koyama
Kyorin University Hospital
Outcome results
None listed