An observational study in Stable Angina, Non-ST-elevation Acute Coronary Syndrome and Unstable Angina, sponsored by TCROSS Co., Ltd.. Recruiting at 32 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by TCROSS Co., Ltd. · Observational
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.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 280 is below the median of 508 across 103 observational studies indexed under Angina, Stable.
Browse Angina, Stable studies →This is the only study on the registry with TCROSS Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects ≥ 18 years of age with de novo LMD with LCx ostium stenosis presenting with stable angina, non-ST-elevation myocardial infarction, or unstable angina that are suitable for percutaneous coronary intervention including W-KBT processes. Approximately 280 subjects at 17 sites in Japan will be enrolled. Subjects will be followed through discharge and 12 months in routine clinical practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects ≥ 18 years of age with de novo LMD with LCx ostium stenosis presenting with stable angina, non-ST-elevation myocardial infarction, or unstable angina that are suitable for percutaneous coronary intervention including W-KBT processes. Approximately 280 subjects at 17 sites in Japan will be enrolled. Subjects will be followed through discharge and 12 months in routine clinical practice.
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
Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT
Fractional flow reserve (FFR) values will be measured before and after each KBT, using either a conventional balloon or PB
Time frame: During PCI procedure
ST-change recovery time
confirming that ECG changes can easily recover even after W-KBT for LMD
Time frame: During PCI procedure
Incidence of periprocedural MI defined by Fourth Universal Definition of Myocardial Infarction (4th UDMI), Academic Research Consortium (ARC)-2 and Society for Cardiovascular Angiography and Interventions (SCAI) definitions
Time frame: Within 12 months of PCI
Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS)
Time frame: During PCI procedure
MACE at 12 months based on lesion characteristics at the LCx ostial lesions and the type of lesion preparation step
Time frame: Within 12 months of PCI
Incidence of symptom onset during W-KBT and reviewing cases showing these symptoms
Time frame: During PCI procedure
Incidence of Treatment Adverse Events [Safety and Tolerability] in patients with low left ventricular ejection fraction (LVEF)
The incidence rate will be calculated using the median LVEF or 40% as the cutoff
Time frame: During PCI procedure & Within 12 months of PCI
The procedural success rate based on the number of LM-PCI experiences
comparing efficacy and safety among various groups based on PCI operators' experience
Time frame: During PCI procedure & Within 12 months of PCI
Late lumen loss
in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)
Time frame: During PCI procedure & Within 12 months of PCI
Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit
Time frame: Within 12 months of PCI
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for May 2027, 36 months after the start.
Of 52 observational studies under Angina, Stable, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
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