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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT1030240071 | Other Identifier | Japan Registry of Clinical Trials |
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| Name | Class |
|---|---|
| Kaneka Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Procedure success rate | indicating the proportion of cases meeting the following three conditions:
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takayuki Warisawa, MD, PhD | Contact | 81-3-3448-6111 | warisawa-tky@umin.ac.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ichinomiya Municipal Hospital | Recruiting | Ichinomiya | Aichi-ken | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42176285 | Derived | Warisawa T, Odagiri S, Ishii M, Nagai T, Asano T, Sotomi Y, Nanasato M, Kawai K, Matsuo H, Saito S. Safety and Efficacy of Double-effect Kissing Balloon Technique in Left Main Bifurcation PCI: Design and Rationale of JDEPTH-LM Registry. Cardiology. 2026 May 23:1-24. doi: 10.1159/000552600. Online ahead of print. |
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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 |
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 |
| Fujita Health University School of Medicine | Not yet recruiting | Toyoake | Aichi-ken | Japan |
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| Chiba University Hospital | Recruiting | Chiba | Chiba | Japan |
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| New Tokyo Hospital | Recruiting | Matsudo | Chiba | Japan |
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| Tokyo Bay Urayasu Ichikawa Medical Center | Recruiting | Urayasu | Chiba | Japan |
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| Ehime Prefectural Central Hospital | Recruiting | Matsuyama | Ehime | Japan |
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| Fukuoka Wajiro Hospital | Recruiting | Fukuoka | Fukuoka | Japan |
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| National Hospital Organization Kyushu Medical Center | Not yet recruiting | Fukuoka | Fukuoka | Japan |
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| Kokura Memorial Hospital | Not yet recruiting | Kitakyushu | Fukuoka | Japan |
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| Gifu Heart Center | Recruiting | Gifu | Gifu | Japan |
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| Gunma University Hospital | Not yet recruiting | Maebashi | Gunma | Japan |
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| Hakodate Municipal Hospital | Recruiting | Hakodate | Hokkaido | Japan |
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| Sapporo Higashi Tokushukai Hospital | Recruiting | Sapporo | Hokkaido | Japan |
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| Tsuchiura Kyodo General Hospital | Recruiting | Tsuchiura | Ibaraki | Japan |
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| Tsukuba Medical Center Hospital | Not yet recruiting | Tsukuba | Ibaraki | Japan |
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| Kanazawa Cardiovascular Hospital | Recruiting | Kanazawa | Ishikawa-ken | Japan |
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| Memorial Heart Center Iwate Medical University | Recruiting | Morioka | Iwate | Japan |
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| Shonan Kamakura General Hospital | Recruiting | Kamakura | Kanagawa | Japan |
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| Kitasato University School of Medicine | Recruiting | Sagamihara | Kanagawa | Japan |
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| Yokosuka Kyosai Hospital | Recruiting | Yokosuka | Kanagawa | Japan |
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| Chikamori Hospital | Recruiting | Kochi | Kochi | Japan |
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| Kumamoto University Hospital | Recruiting | Kumamoto | Kumamoto | Japan |
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| Shinshu University Hospital | Recruiting | Matsumoto | Nagano | Japan |
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| Kurashiki Central Hospital | Not yet recruiting | Kurashiki | Okayama-ken | Japan |
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| Urasoe General Hospital | Recruiting | Urasoe | Okinawa | Japan |
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| The University of Tokyo Hospital | Not yet recruiting | Bunkyo | Tokyo | Japan |
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| Moriyama Memorial Hospital | Recruiting | Edogawa City | Tokyo | Japan |
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| Sakakibara Heart Institute | Recruiting | Fuchū | Tokyo | Japan |
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| Jikei University Katsushika Medical Center | Recruiting | Katsushika-ku | Tokyo | Japan |
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| NTT Medical Center Tokyo | Recruiting | Shinagawa | Tokyo | Japan |
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| Keio University Hospital | Not yet recruiting | Shinjuku | Tokyo | Japan |
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| Japanese Red Cross Wakayama Medical Center | Recruiting | Wakayama | Wakayama | Japan |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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