Registry for coronary intervention using drug-eluting balloons for left main disease

Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)

This study is testing a new balloon technique for treating patients with left main coronary artery disease to see if it is safe and effective.

Quick facts

• Study type: Observational
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: TCROSS Co., Ltd. (Industry-sponsored)
• Locations: 32 sites (Ichinomiya, Aichi-ken and 31 other locations)
• Trial ID: NCT06436092 on ClinicalTrials.gov

What this trial studies

The JDEPTH-LM Registry is a prospective, observational, multi-center initiative aimed at assessing the efficacy and safety of the Double-effect kissing balloon technique (W-KBT) in patients with left main coronary artery disease. Participants will undergo percutaneous coronary intervention (PCI) using a combination of perfusion balloons and drug-coated balloons, with treatment decisions made by a local Heart Team. The study will continuously register cases and evaluate outcomes based on standard care protocols, ensuring informed consent is obtained from all participants.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stable coronary artery disease or unstable angina and confirmed left main disease.

Not a fit: Patients who have had a recent ST-elevation myocardial infarction or are in cardiogenic shock may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients with left main coronary artery disease.

How similar studies have performed: Other studies have shown promise with similar techniques in coronary interventions, suggesting potential for success in this approach.

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

Where this trial is running

Ichinomiya, Aichi-ken and 31 other locations

• Ichinomiya Municipal Hospital — Ichinomiya, Aichi-ken, Japan (Recruiting)
• Fujita Health University School of Medicine — Toyoake, Aichi-ken, Japan (Not_yet_recruiting)
• Chiba University Hospital — Chiba, Chiba, Japan (Recruiting)
• New Tokyo Hospital — Matsudo, Chiba, Japan (Recruiting)
• Tokyo Bay Urayasu Ichikawa Medical Center — Urayasu, Chiba, Japan (Recruiting)
• Ehime Prefectural Central Hospital — Matsuyama, Ehime, Japan (Recruiting)
• Fukuoka Wajiro Hospital — Fukuoka, Fukuoka, Japan (Recruiting)
• National Hospital Organization Kyushu Medical Center — Fukuoka, Fukuoka, Japan (Not_yet_recruiting)
• Kokura Memorial Hospital — Kitakyushu, Fukuoka, Japan (Not_yet_recruiting)
• Gifu Heart Center — Gifu, Gifu, Japan (Recruiting)
• Gunma University Hospital — Maebashi, Gunma, Japan (Not_yet_recruiting)
• Hakodate Municipal Hospital — Hakodate, Hokkaido, Japan (Recruiting)
• Sapporo Higashi Tokushukai Hospital — Sapporo, Hokkaido, Japan (Recruiting)
• Tsuchiura Kyodo General Hospital — Tsuchiura, Ibaraki, Japan (Recruiting)
• Tsukuba Medical Center Hospital — Tsukuba, Ibaraki, Japan (Not_yet_recruiting)
• Kanazawa Cardiovascular Hospital — Kanazawa, Ishikawa-ken, Japan (Recruiting)
• Memorial Heart Center Iwate Medical University — Morioka, Iwate, Japan (Recruiting)
• Shonan Kamakura General Hospital — Kamakura, Kanagawa, Japan (Recruiting)
• Kitasato University School of Medicine — Sagamihara, Kanagawa, Japan (Recruiting)
• Yokosuka Kyosai Hospital — Yokosuka, Kanagawa, Japan (Recruiting)
• Chikamori Hospital — Kochi, Kochi, Japan (Recruiting)
• Kumamoto University Hospital — Kumamoto, Kumamoto, Japan (Recruiting)
• Shinshu University Hospital — Matsumoto, Nagano, Japan (Recruiting)
• Kurashiki Central Hospital — Kurashiki, Okayama-ken, Japan (Not_yet_recruiting)
• Urasoe General Hospital — Urasoe, Okinawa, Japan (Recruiting)
• The University of Tokyo Hospital — Bunkyo, Tokyo, Japan (Not_yet_recruiting)
• Moriyama Memorial Hospital — Edogawa City, Tokyo, Japan (Recruiting)
• Sakakibara Heart Institute — Fuchū, Tokyo, Japan (Recruiting)
• Jikei University Katsushika Medical Center — Katsushika-ku, Tokyo, Japan (Recruiting)
• NTT Medical Center Tokyo — Shinagawa, Tokyo, Japan (Recruiting)
• Keio University Hospital — Shinjuku, Tokyo, Japan (Not_yet_recruiting)
• Japanese Red Cross Wakayama Medical Center — Wakayama, Wakayama, Japan (Recruiting)

Study contacts

• Study coordinator: Takayuki Warisawa, MD, PhD

Conditions Stable Angina; Non-ST-elevation Acute Coronary Syndrome; Unstable Angina; Ischemic heart disease