Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06436092

Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ichinomiya Municipal Hospital, Ichinomiya, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Patient with stable coronary artery disease, non-ST-elevation myocardial infarction, or unstable angina
  • Left main disease confirmed by coronary angiography or coronary CT angiography
  • Clinical and anatomical eligibility for PCI as agreed by the local Heart Team
  • Patient with consent prior to undergoing PCI
  • Left main Medina classification (1,1,1), (1,0,1), (0,1,1), (0,0,1) confirmed by coronary angiography
  • De novo target lesion in LMT-LAD amenable for crossover stenting with provisional side-branch approach as determined by PCI operator
  • De novo ostial LCx lesions
  • Lesion indicated in No. 8 with a length of less than 10 mm or a stenosis of less than 70% confirmed by coronary angiography

Exclusion criteria

  • Inability to provide written informed consent
  • Patient with a history of ST-elevation myocardial infarction within the previous 1 week
  • Patient in a state of cardiogenic shock
  • Patient with a history of coronary artery bypass grafting
  • Patient with malignant tumors or other conditions with a life expectancy of less than one year
  • Patient considered suitable for stent placement in the ostial LCx from a medical perspective
  • Patient considered unsuitable for anti-thrombotic therapy after PCI
  • Other patient whom the investigator deems unsuitable for the safe conduct of LM-PCI, including W-KBT

Treatment and study plan

Primary outcomes

  1. Procedure success rate

    Time frame: During PCI procedure

    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
  2. Major adverse cardiovascular event (MACE) at 12 months

    Time frame: Within 12 months of PCI procedure

    consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease

Secondary outcomes

  1. Time to ST-change from DCB inflation

    Time frame: During PCI procedure

    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

  2. Total DCB Inflation time

    Time frame: During PCI procedure

    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

  3. Maximum changes in blood pressure and heart rate

    Time frame: During PCI procedure

    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)

  4. Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT

    Time frame: During PCI procedure

    confirming that hemodynamics is not disturbed by W-KBT for LMD

  5. Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium

    Time frame: Within 12 months of PCI

    confirming the frequency of occurrences for each component of MACE

Other outcomes

  1. Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT

    Time frame: During PCI procedure

    Fractional flow reserve (FFR) values will be measured before and after each KBT, using either a conventional balloon or PB

  2. ST-change recovery time

    Time frame: During PCI procedure

    confirming that ECG changes can easily recover even after W-KBT for LMD

  3. 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

  4. Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS)

    Time frame: During PCI procedure

  5. 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

  6. Incidence of symptom onset during W-KBT and reviewing cases showing these symptoms

    Time frame: During PCI procedure

  7. Incidence of Treatment Adverse Events [Safety and Tolerability] in patients with low left ventricular ejection fraction (LVEF)

    Time frame: During PCI procedure & Within 12 months of PCI

    The incidence rate will be calculated using the median LVEF or 40% as the cutoff

  8. The procedural success rate based on the number of LM-PCI experiences

    Time frame: During PCI procedure & Within 12 months of PCI

    comparing efficacy and safety among various groups based on PCI operators' experience

  9. Late lumen loss

    Time frame: During PCI procedure & Within 12 months of PCI

    in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)

  10. Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit

    Time frame: Within 12 months of PCI

Study contacts

Contact information is provided by the study sponsor or research team.

Takayuki Warisawa, MD, PhD

CONTACT

[email protected]

81-3-3448-6111

Sponsors and collaborators

Lead sponsor

TCROSS Co., Ltd.

Industry

Collaborators

  • Kaneka Corporation

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
May 30, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.