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.

Study Overview

• Status: Recruiting
• Conditions: Stable Angina; Unstable Angina; Non-ST-elevation Acute Coronary Syndrome

Detailed Description

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 (Estimated): 280

Contacts and Locations

• Study Contact: Name: Takayuki Warisawa, MD, PhD; Phone Number: 81-3-3448-6111; Email: warisawa-tky@umin.ac.jp

Study Locations

• Japan
  • Chiba, Japan
    • Recruiting
    • Chiba University Hospital
    • Contact: Yuichi Saito
  • Fukuoka, Japan
    • Not yet recruiting
    • National Hospital Organization Kyushu Medical Center
    • Contact: Yoshinobu Murasato
  • Fukuoka, Japan
    • Recruiting
    • Fukuoka Wajiro Hospital
    • Contact: Takeshi Serikawa
  • Gifu, Japan
    • Recruiting
    • Gifu Heart Center
    • Contact: Yoshiaki Kawase
  • Kochi, Japan
    • Recruiting
    • Chikamori Hospital
    • Contact: Ryu-Ichirou Imai
  • Kumamoto, Japan
    • Recruiting
    • Kumamoto University Hospital
    • Contact: Kenichi Tsujita
  • Wakayama, Japan
    • Recruiting
    • Japanese Red Cross Wakayama Medical Center
    • Contact: Junichi Tazaki
  • Aichi
    • Ichinomiya, Aichi, Japan
      • Recruiting
      • Ichinomiya Municipal Hospital
      • Contact: Hisaaki Ishiguro
    • Toyoake, Aichi, Japan
      • Not yet recruiting
      • Fujita Health University School of Medicine
      • Contact: Takashi Muramatsu
  • Chiba
    • Matsudo, Chiba, Japan
      • Recruiting
      • New Tokyo Hospital
      • Contact: Koji Hozawa
    • Urayasu, Chiba, Japan
      • Recruiting
      • Tokyo Bay Urayasu Ichikawa Medical Center
      • Contact: Masahiko Noguchi
  • Ehime
    • Matsuyama, Ehime, Japan
      • Recruiting
      • Ehime Prefectural Central Hospital
      • Contact: Hideki Okayama
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan
      • Not yet recruiting
      • Kokura Memorial Hospital
      • Contact: Takenori Domei
  • Gunma
    • Maebashi, Gunma, Japan
      • Not yet recruiting
      • Gunma University Hospital
      • Contact: Takashi Nagasaka
  • Hokkaido
    • Hakodate, Hokkaido, Japan
      • Recruiting
      • Hakodate Municipal Hospital
      • Contact: Yusuke Tokuda
    • Sapporo, Hokkaido, Japan
      • Recruiting
      • Sapporo Higashi Tokushukai Hospital
      • Contact: Yuki Katagiri
  • Ibaraki
    • Tsuchiura, Ibaraki, Japan
      • Recruiting
      • Tsuchiura Kyodo General Hospital
      • Contact: Tsunekazu Kakuta
    • Tsukuba, Ibaraki, Japan
      • Not yet recruiting
      • Tsukuba Medical Center Hospital
      • Contact: Hidetaka Nishina
  • Ishikawa
    • Kanazawa, Ishikawa, Japan
      • Recruiting
      • Kanazawa Cardiovascular Hospital
      • Contact: Hidenobu Terai
  • Iwate
    • Morioka, Iwate, Japan
      • Recruiting
      • Memorial Heart Center Iwate Medical University
      • Contact: Kai Ninomiya
  • Kanagawa
    • Kamakura, Kanagawa, Japan
      • Recruiting
      • Shonan Kamakura General Hospital
      • Contact: Koki Shishido
    • Sagamihara, Kanagawa, Japan
      • Recruiting
      • Kitasato University School of Medicine
      • Contact: Yoshiyasu Minami
    • Yokosuka, Kanagawa, Japan
      • Recruiting
      • Yokosuka Kyosai Hospital
      • Contact: Tadashi Murai
  • Nagano
    • Matsumoto, Nagano, Japan
      • Recruiting
      • Shinshu University Hospital
      • Contact: Yasushi Ueki
  • Okayama
    • Kurashiki, Okayama, Japan
      • Not yet recruiting
      • Kurashiki Central Hospital
      • Contact: Hiroyuki Tanaka
  • Okinawa
    • Urasoe, Okinawa, Japan
      • Recruiting
      • Urasoe General Hospital
      • Contact: Marohito Nakata
  • Tokyo
    • Bunkyo, Tokyo, Japan
      • Not yet recruiting
      • The University of Tokyo Hospital
      • Contact: Hiroyuki Kiriyama
    • Edogawa, Tokyo, Japan
      • Recruiting
      • Moriyama Memorial Hospital
      • Contact: Arihiro Kiyosue
    • Fuchu, Tokyo, Japan
      • Recruiting
      • Sakakibara Heart Institute
      • Contact: Kenichi Hagiya
    • Katsushika, Tokyo, Japan
      • Recruiting
      • Jikei University Katsushika Medical Center
      • Contact: Ryosuke Itakura
    • Shinagawa, Tokyo, Japan
      • Recruiting
      • NTT Medical Center Tokyo
      • Contact: Takayuki Warisawa
    • Shinjuku, Tokyo, Japan
      • Not yet recruiting
      • Keio University Hospital
      • Contact: Yohei Numasawa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Patient with stable coronary artery disease, non-ST-elevation myocardial infarction, or unstable angina
3. Left main disease confirmed by coronary angiography or coronary CT angiography
4. Clinical and anatomical eligibility for PCI as agreed by the local Heart Team
5. Patient with consent prior to undergoing PCI
6. Left main Medina classification (1,1,1), (1,0,1), (0,1,1), (0,0,1) confirmed by coronary angiography
7. De novo target lesion in LMT-LAD amenable for crossover stenting with provisional side-branch approach as determined by PCI operator
8. De novo ostial LCx lesions
9. 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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

JDEPTH-LM Registry Participants; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Within 12 months of PCI procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	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	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	Within 12 months of PCI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During PCI procedure
ST-change recovery time	confirming that ECG changes can easily recover even after W-KBT for LMD	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		Within 12 months of PCI
Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS)		During PCI procedure
MACE at 12 months based on lesion characteristics at the LCx ostial lesions and the type of lesion preparation step		Within 12 months of PCI
Incidence of symptom onset during W-KBT and reviewing cases showing these symptoms		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	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	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)	During PCI procedure & Within 12 months of PCI
Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit		Within 12 months of PCI

Collaborators and Investigators

• Sponsor: TCROSS Co., Ltd.
• Collaborators: Kaneka Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Ischemic heart disease
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Chest Pain; Coronary Artery Disease; Acute Coronary Syndrome; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: JDEPTH-LM Registry; jRCT1030240071 (Other Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No