NIPH Clinical Trials Search

A Prospective, Multicenter, Randomized Trial of New Cutting Balloon Versus Conventional Balloon for the Treatment of Severe Calcified Lesion

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Ischemic heart disease
Date of first enrollment	08/10/2020
Target sample size	170
Countries of recruitment
Study type	Interventional
Intervention(s)	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 of randomization will be determined separately by the person responsible for randomization.

Outcome(s)

Primary Outcome

Minimum stent area (MSA)

Secondary Outcome

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)

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.