Stable AnginaNCT06436092
Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
An observational study of Stable Angina and Non-ST-elevation Acute Coronary Syndrome, run by TCROSS Co., Ltd. at 32 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Non-ST-elevation Acute Coronary Syndrome, Unstable Angina
- How many people
- 280 participants
- Where
- 32 sitesJapan
- Study dates
- 27 May 2024to 31 Dec 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
Japan32 sites, 32 recruiting
- Not yet recruiting
The University of Tokyo Hospital
Bunkyo, Tokyo
Hiroyuki Kiriyama
- Recruiting
Chiba University Hospital
Chiba, Chiba
Yuichi Saito
- Recruiting
Moriyama Memorial Hospital
Edogawa City, Tokyo
Arihiro Kiyosue
- Recruiting
Sakakibara Heart Institute
Fuchū, Tokyo
Kenichi Hagiya
- Recruiting
Fukuoka Wajiro Hospital
Fukuoka, Fukuoka
Takeshi Serikawa
- Not yet recruiting
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka
Yoshinobu Murasato
- Recruiting
Gifu Heart Center
Gifu, Gifu
Yoshiaki Kawase
- Recruiting
Hakodate Municipal Hospital
Hakodate, Hokkaido
Yusuke Tokuda
- Recruiting
Ichinomiya Municipal Hospital
Ichinomiya, Aichi-ken
Hisaaki Ishiguro
- Recruiting
Shonan Kamakura General Hospital
Kamakura, Kanagawa
Koki Shishido
- Recruiting
Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken
Hidenobu Terai
- Recruiting
Jikei University Katsushika Medical Center
Katsushika-ku, Tokyo
Ryosuke Itakura
- Not yet recruiting
Kokura Memorial Hospital
Kitakyushu, Fukuoka
Takenori Domei
- Recruiting
Chikamori Hospital
Kochi, Kochi
Ryu-Ichirou Imai
- Recruiting
Kumamoto University Hospital
Kumamoto, Kumamoto
Kenichi Tsujita
- Not yet recruiting
Kurashiki Central Hospital
Kurashiki, Okayama-ken
Hiroyuki Tanaka
- Not yet recruiting
Gunma University Hospital
Maebashi, Gunma
Takashi Nagasaka
- Recruiting
New Tokyo Hospital
Matsudo, Chiba
Koji Hozawa
- Recruiting
Shinshu University Hospital
Matsumoto, Nagano
Yasushi Ueki
- Recruiting
Ehime Prefectural Central Hospital
Matsuyama, Ehime
Hideki Okayama
- Recruiting
Memorial Heart Center Iwate Medical University
Morioka, Iwate
Kai Ninomiya
- Recruiting
Kitasato University School of Medicine
Sagamihara, Kanagawa
Yoshiyasu Minami
- Recruiting
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido
Yuki Katagiri
- Recruiting
NTT Medical Center Tokyo
Shinagawa, Tokyo
Takayuki Warisawa
- Not yet recruiting
Keio University Hospital
Shinjuku, Tokyo
Yohei Numasawa
- Not yet recruiting
Fujita Health University School of Medicine
Toyoake, Aichi-ken
Takashi Muramatsu
- Recruiting
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaraki
Tsunekazu Kakuta
- Not yet recruiting
Tsukuba Medical Center Hospital
Tsukuba, Ibaraki
Hidetaka Nishina
- Recruiting
Urasoe General Hospital
Urasoe, Okinawa
Marohito Nakata
- Recruiting
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba
Masahiko Noguchi
- Recruiting
Japanese Red Cross Wakayama Medical Center
Wakayama, Wakayama
Junichi Tazaki
- Recruiting
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa
Tadashi Murai
About this study
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.
Read the 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.
- Keywords
- Ischemic heart disease
- Medical subject headings
- Angina, Stable, Angina, Unstable, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Within 12 months of PCI procedure
Secondary outcomes (5)
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Within 12 months of PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start27 May 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- TCROSS Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaneka Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436092
- Sponsor's protocol ID
- JDEPTH-LM Registry
- Other IDs
- jRCT1030240071
- Status last verified
- Mar 2025
- First submitted
- 10 May 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
- ClinicalTrials.gov ID
- NCT06436092
- Acronym / sponsor ID
- JDEPTH-LM Registry
- Keywords
- Ischemic heart disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- TCROSS Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kaneka Corporation
- Study start
- 27 May 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
5 secondary outcomes
Time to ST-change from DCB inflation
Time frame: During PCI procedure
Total DCB Inflation time
Time frame: During PCI procedure
Maximum changes in blood pressure and heart rate
Time frame: During PCI procedure
Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT
Time frame: During PCI procedure
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina and Non-ST-elevation Acute Coronary Syndrome, run by TCROSS Co., Ltd. at 32 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takayuki Warisawa, MD, PhD (81-3-3448-6111, warisawa-tky@umin.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success rate (time frame: During PCI procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.