JDEPTH-LM Registry is a prospective, observational, multi-center study designed for the efficacy and safety of Double-effect kissing balloon technique (W-KBT) in left main (LM) bifurcation percutaneous coronary intervention (PCI) using Perfusion balloon (PB) and Drug coated balloon (DCB) in patients with left main coronary artery disease (LMD) with left circumflex artery (LCx) ostium stenosis.
JDEPTH-LM Registry is a prospective observational multi-center study. The investigators will enroll and treat patients in the registry who meet the selection criteria under usual care and for whom PCI with W-KBT following on crossover stenting for LMT-LAD direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) is the optimal treatment. The operators shall obtain oral or written consent from patients who meet the criteria before performing PCI, indicating the intention to perform PCI with W-KBT, and shall keep records. The investigators will continuously register cases attempting PCI with W-KBT according to the protocol and evaluate its efficacy and safety using data from this multi-center registry.
Study Type
OBSERVATIONAL
Enrollment
280
Ichinomiya Municipal Hospital
Ichinomiya, Aichi-ken, Japan
RECRUITINGFujita Health University School of Medicine
Toyoake, Aichi-ken, Japan
NOT_YET_RECRUITINGChiba University Hospital
Chiba, Chiba, Japan
RECRUITINGNew Tokyo Hospital
Matsudo, Chiba, Japan
Procedure success rate
indicating the proportion of cases meeting the following three conditions: * Device delivery success * Achievement of DCB expansion for 30 seconds or more * No bailout stenting performed in the LCx
Time frame: During PCI procedure
Major adverse cardiovascular event (MACE) at 12 months
consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease
Time frame: Within 12 months of PCI procedure
Time to ST-change from DCB inflation
confirming the time from the initiation of W-KBT to any ST elevation/depression in the electrocardiogram (ECG) to evaluate the safety of the procedure
Time frame: During PCI procedure
Total DCB Inflation time
confirming the duration for which the inflation of the DCB can be sustained during W-KBT, as the recommendation time of DCB inflation is at least 30 seconds
Time frame: During PCI procedure
Maximum changes in blood pressure and heart rate
confirming the extent of blood pressure and heart rate changes resulting from maintaining W-KBT for 30 seconds or longer in the left main coronary trunk (LMT)
Time frame: During PCI procedure
Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT
confirming that hemodynamics is not disturbed by W-KBT for LMD
Time frame: During PCI procedure
Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium
confirming the frequency of occurrences for each component of MACE
Time frame: Within 12 months of PCI
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Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, Japan
RECRUITINGEhime Prefectural Central Hospital
Matsuyama, Ehime, Japan
RECRUITINGFukuoka Wajiro Hospital
Fukuoka, Fukuoka, Japan
RECRUITINGNational Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, Japan
NOT_YET_RECRUITINGKokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
NOT_YET_RECRUITINGGifu Heart Center
Gifu, Gifu, Japan
RECRUITING...and 22 more locations