Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-25 @ 4:26 PM
Study NCT ID:
NCT06436092
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2024-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT', 'timeFrame': 'During PCI procedure', 'description': 'Fractional flow reserve (FFR) values will be measured before and after each KBT, using either a conventional balloon or PB'}, {'measure': 'ST-change recovery time', 'timeFrame': 'During PCI procedure', 'description': 'confirming that ECG changes can easily recover even after W-KBT for LMD'}, {'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', 'description': 'The incidence rate will be calculated using the median LVEF or 40% as the cutoff'}, {'measure': 'The procedural success rate based on the number of LM-PCI experiences', 'timeFrame': 'During PCI procedure & Within 12 months of PCI', 'description': "comparing efficacy and safety among various groups based on PCI operators' experience"}, {'measure': 'Late lumen loss', 'timeFrame': 'During PCI procedure & Within 12 months of PCI', 'description': 'in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)'}, {'measure': 'Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit', 'timeFrame': 'Within 12 months of PCI'}], 'primaryOutcomes': [{'measure': 'Procedure success rate', 'timeFrame': 'During PCI procedure', 'description': 'indicating the proportion of cases meeting the following three conditions:\n\n* Device delivery success\n* Achievement of DCB expansion for 30 seconds or more\n* No bailout stenting performed in the LCx'}, {'measure': 'Major adverse cardiovascular event (MACE) at 12 months', 'timeFrame': 'Within 12 months of PCI procedure', 'description': 'consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease'}], 'secondaryOutcomes': [{'measure': 'Time to ST-change from DCB inflation', 'timeFrame': 'During PCI procedure', 'description': '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'}, {'measure': 'Total DCB Inflation time', 'timeFrame': 'During PCI procedure', 'description': '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'}, {'measure': 'Maximum changes in blood pressure and heart rate', 'timeFrame': 'During PCI procedure', 'description': '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)'}, {'measure': 'Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT', 'timeFrame': 'During PCI procedure', 'description': 'confirming that hemodynamics is not disturbed by W-KBT for LMD'}, {'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', 'description': 'confirming the frequency of occurrences for each component of MACE'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic heart disease'], 'conditions': ['Stable Angina', 'Non-ST-elevation Acute Coronary Syndrome', 'Unstable Angina']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patient with stable coronary artery disease, non-ST-elevation myocardial infarction, or unstable angina\n3. Left main disease confirmed by coronary angiography or coronary CT angiography\n4. Clinical and anatomical eligibility for PCI as agreed by the local Heart Team\n5. Patient with consent prior to undergoing PCI\n6. Left main Medina classification (1,1,1), (1,0,1), (0,1,1), (0,0,1) confirmed by coronary angiography\n7. De novo target lesion in LMT-LAD amenable for crossover stenting with provisional side-branch approach as determined by PCI operator\n8. De novo ostial LCx lesions\n9. Lesion indicated in No. 8 with a length of less than 10 mm or a stenosis of less than 70% confirmed by coronary angiography\n\nExclusion Criteria:\n\n1. Inability to provide written informed consent\n2. Patient with a history of ST-elevation myocardial infarction within the previous 1 week\n3. Patient in a state of cardiogenic shock\n4. Patient with a history of coronary artery bypass grafting\n5. Patient with malignant tumors or other conditions with a life expectancy of less than one year\n6. Patient considered suitable for stent placement in the ostial LCx from a medical perspective\n7. Patient considered unsuitable for anti-thrombotic therapy after PCI\n8. Other patient whom the investigator deems unsuitable for the safe conduct of LM-PCI, including W-KBT'}, 'identificationModule': {'nctId': 'NCT06436092', 'briefTitle': 'Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCROSS Co., Ltd.'}, 'officialTitle': 'Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)', 'orgStudyIdInfo': {'id': 'JDEPTH-LM Registry'}, 'secondaryIdInfos': [{'id': 'jRCT1030240071', 'type': 'OTHER', 'domain': 'Japan Registry of Clinical Trials'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'JDEPTH-LM Registry Participants', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ichinomiya', 'state': 'Aichi-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hisaaki Ishiguro', 'role': 'CONTACT'}], 'facility': 'Ichinomiya Municipal Hospital', 'geoPoint': {'lat': 35.3, 'lon': 136.8}}, {'city': 'Toyoake', 'state': 'Aichi-ken', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takashi Muramatsu', 'role': 'CONTACT'}], 'facility': 'Fujita Health University School of Medicine', 'geoPoint': {'lat': 35.038, 'lon': 136.99931}}, {'city': 'Chiba', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yuichi Saito', 'role': 'CONTACT'}], 'facility': 'Chiba University Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Matsudo', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Koji Hozawa', 'role': 'CONTACT'}], 'facility': 'New Tokyo Hospital', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'city': 'Urayasu', 'state': 'Chiba', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Masahiko Noguchi', 'role': 'CONTACT'}], 'facility': 'Tokyo Bay Urayasu Ichikawa Medical Center', 'geoPoint': {'lat': 35.65879, 'lon': 139.90055}}, {'city': 'Matsuyama', 'state': 'Ehime', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hideki Okayama', 'role': 'CONTACT'}], 'facility': 'Ehime Prefectural Central Hospital', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takeshi Serikawa', 'role': 'CONTACT'}], 'facility': 'Fukuoka Wajiro Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoshinobu Murasato', 'role': 'CONTACT'}], 'facility': 'National Hospital Organization Kyushu Medical Center', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takenori Domei', 'role': 'CONTACT'}], 'facility': 'Kokura Memorial Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Gifu', 'state': 'Gifu', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoshiaki Kawase', 'role': 'CONTACT'}], 'facility': 'Gifu Heart Center', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Maebashi', 'state': 'Gunma', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takashi Nagasaka', 'role': 'CONTACT'}], 'facility': 'Gunma University Hospital', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Hakodate', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yusuke Tokuda', 'role': 'CONTACT'}], 'facility': 'Hakodate Municipal Hospital', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yuki Katagiri', 'role': 'CONTACT'}], 'facility': 'Sapporo Higashi Tokushukai Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Tsuchiura', 'state': 'Ibaraki', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Tsunekazu Kakuta', 'role': 'CONTACT'}], 'facility': 'Tsuchiura Kyodo General Hospital', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}, {'city': 'Tsukuba', 'state': 'Ibaraki', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hidetaka Nishina', 'role': 'CONTACT'}], 'facility': 'Tsukuba Medical Center Hospital', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hidenobu Terai', 'role': 'CONTACT'}], 'facility': 'Kanazawa Cardiovascular Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Morioka', 'state': 'Iwate', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kai Ninomiya', 'role': 'CONTACT'}], 'facility': 'Memorial Heart Center Iwate Medical University', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'city': 'Kamakura', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Koki Shishido', 'role': 'CONTACT'}], 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'city': 'Sagamihara', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoshiyasu Minami', 'role': 'CONTACT'}], 'facility': 'Kitasato University School of Medicine', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Yokosuka', 'state': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Tadashi Murai', 'role': 'CONTACT'}], 'facility': 'Yokosuka Kyosai Hospital', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'city': 'Kochi', 'state': 'Kochi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Ryu-Ichirou Imai', 'role': 'CONTACT'}], 'facility': 'Chikamori Hospital', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kumamoto', 'state': 'Kumamoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kenichi Tsujita', 'role': 'CONTACT'}], 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Matsumoto', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yasushi Ueki', 'role': 'CONTACT'}], 'facility': 'Shinshu University Hospital', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiroyuki Tanaka', 'role': 'CONTACT'}], 'facility': 'Kurashiki Central Hospital', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Urasoe', 'state': 'Okinawa', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Marohito Nakata', 'role': 'CONTACT'}], 'facility': 'Urasoe General Hospital', 'geoPoint': {'lat': 26.25902, 'lon': 127.73012}}, {'city': 'Bunkyo', 'state': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiroyuki Kiriyama', 'role': 'CONTACT'}], 'facility': 'The University of Tokyo Hospital'}, {'city': 'Edogawa City', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Arihiro Kiyosue', 'role': 'CONTACT'}], 'facility': 'Moriyama Memorial Hospital', 'geoPoint': {'lat': 35.69225, 'lon': 139.87308}}, {'city': 'Fuchū', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kenichi Hagiya', 'role': 'CONTACT'}], 'facility': 'Sakakibara Heart Institute', 'geoPoint': {'lat': 35.67452, 'lon': 139.48216}}, {'city': 'Katsushika-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Ryosuke Itakura', 'role': 'CONTACT'}], 'facility': 'Jikei University Katsushika Medical Center', 'geoPoint': {'lat': 35.73333, 'lon': 139.85}}, {'city': 'Shinagawa', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takayuki Warisawa', 'role': 'CONTACT'}], 'facility': 'NTT Medical Center Tokyo'}, {'city': 'Shinjuku', 'state': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yohei Numasawa', 'role': 'CONTACT'}], 'facility': 'Keio University Hospital', 'geoPoint': {'lat': 35.69115, 'lon': 139.70854}}, {'city': 'Wakayama', 'state': 'Wakayama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Junichi Tazaki', 'role': 'CONTACT'}], 'facility': 'Japanese Red Cross Wakayama Medical Center', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'centralContacts': [{'name': 'Takayuki Warisawa, MD, PhD', 'role': 'CONTACT', 'email': 'warisawa-tky@umin.ac.jp', 'phone': '81-3-3448-6111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCROSS Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kaneka Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}