Clinical trial NCT06436092: Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
Official title: Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stable Angina
Non-ST-elevation Acute Coronary Syndrome
Unstable Angina
Keywords: Ischemic heart disease
Lead sponsor: TCROSS Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kaneka Corporation
First posted: 2024-05-30
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedure success rate
timeFrame: During PCI procedure
measure: Major adverse cardiovascular event (MACE) at 12 months
timeFrame: Within 12 months of PCI procedure
Secondary outcomes:
measure: Time to ST-change from DCB inflation
timeFrame: During PCI procedure
measure: Total DCB Inflation time
timeFrame: During PCI procedure
measure: Maximum changes in blood pressure and heart rate
timeFrame: During PCI procedure
measure: Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT
timeFrame: During PCI procedure
measure: Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium
timeFrame: Within 12 months of PCI
Other outcomes:
measure: Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT
timeFrame: During PCI procedure
measure: ST-change recovery time
timeFrame: During PCI procedure
measure: 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
timeFrame: Within 12 months of PCI
measure: Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS)
timeFrame: During PCI procedure
measure: MACE at 12 months based on lesion characteristics at the LCx ostial lesions and the type of lesion preparation step
timeFrame: Within 12 months of PCI
measure: Incidence of symptom onset during W-KBT and reviewing cases showing these symptoms
timeFrame: During PCI procedure
measure: Incidence of Treatment Adverse Events [Safety and Tolerability] in patients with low left ventricular ejection fraction (LVEF)
timeFrame: During PCI procedure & Within 12 months of PCI
measure: The procedural success rate based on the number of LM-PCI experiences
timeFrame: During PCI procedure & Within 12 months of PCI
measure: Late lumen loss
timeFrame: During PCI procedure & Within 12 months of PCI
measure: Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit
timeFrame: Within 12 months of PCI
Locations:
city: Ichinomiya
country: Japan
facility: Ichinomiya Municipal Hospital
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University School of Medicine
state: Aichi
city: Matsudo
country: Japan
facility: New Tokyo Hospital
state: Chiba
city: Urayasu
country: Japan
facility: Tokyo Bay Urayasu Ichikawa Medical Center
state: Chiba
city: Matsuyama
country: Japan
facility: Ehime Prefectural Central Hospital
state: Ehime
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Hakodate
country: Japan
facility: Hakodate Municipal Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Tsuchiura
country: Japan
facility: Tsuchiura Kyodo General Hospital
state: Ibaraki
city: Tsukuba
country: Japan
facility: Tsukuba Medical Center Hospital
state: Ibaraki
city: Kanazawa
country: Japan
facility: Kanazawa Cardiovascular Hospital
state: Ishikawa
city: Morioka
country: Japan
facility: Memorial Heart Center Iwate Medical University
state: Iwate
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University School of Medicine
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital
state: Kanagawa
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Urasoe
country: Japan
facility: Urasoe General Hospital
state: Okinawa
city: Bunkyo
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Edogawa
country: Japan
facility: Moriyama Memorial Hospital
state: Tokyo
city: Fuchu
country: Japan
facility: Sakakibara Heart Institute
state: Tokyo
city: Katsushika
country: Japan
facility: Jikei University Katsushika Medical Center
state: Tokyo
city: Shinagawa
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinjuku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: Fukuoka Wajiro Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Gifu
country: Japan
facility: Gifu Heart Center
city: Kochi
country: Japan
facility: Chikamori Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Wakayama
country: Japan
facility: Japanese Red Cross Wakayama Medical Center
Study officials:
References: