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

Status: Recruiting
Location: See all (32) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

• 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

Locations
Other Locations
Japan
The University of Tokyo Hospital
NOT_YET_RECRUITING
Bunkyo
Chiba University Hospital
RECRUITING
Chiba
Moriyama Memorial Hospital
RECRUITING
Edogawa City
Sakakibara Heart Institute
RECRUITING
Fuchū
Fukuoka Wajiro Hospital
RECRUITING
Fukuoka
National Hospital Organization Kyushu Medical Center
NOT_YET_RECRUITING
Fukuoka
Gifu Heart Center
RECRUITING
Gifu
Hakodate Municipal Hospital
RECRUITING
Hakodate
Ichinomiya Municipal Hospital
RECRUITING
Ichinomiya
Shonan Kamakura General Hospital
RECRUITING
Kamakura
Kanazawa Cardiovascular Hospital
RECRUITING
Kanazawa
Jikei University Katsushika Medical Center
RECRUITING
Katsushika-ku
Kokura Memorial Hospital
NOT_YET_RECRUITING
Kitakyushu
Chikamori Hospital
RECRUITING
Kochi
Kumamoto University Hospital
RECRUITING
Kumamoto
Kurashiki Central Hospital
NOT_YET_RECRUITING
Kurashiki
Gunma University Hospital
NOT_YET_RECRUITING
Maebashi
New Tokyo Hospital
RECRUITING
Matsudo
Shinshu University Hospital
RECRUITING
Matsumoto
Ehime Prefectural Central Hospital
RECRUITING
Matsuyama
Memorial Heart Center Iwate Medical University
RECRUITING
Morioka
Kitasato University School of Medicine
RECRUITING
Sagamihara
Sapporo Higashi Tokushukai Hospital
RECRUITING
Sapporo
NTT Medical Center Tokyo
RECRUITING
Shinagawa
Keio University Hospital
NOT_YET_RECRUITING
Shinjuku
Fujita Health University School of Medicine
NOT_YET_RECRUITING
Toyoake
Tsuchiura Kyodo General Hospital
RECRUITING
Tsuchiura
Tsukuba Medical Center Hospital
NOT_YET_RECRUITING
Tsukuba
Urasoe General Hospital
RECRUITING
Urasoe
Tokyo Bay Urayasu Ichikawa Medical Center
RECRUITING
Urayasu
Japanese Red Cross Wakayama Medical Center
RECRUITING
Wakayama
Yokosuka Kyosai Hospital
RECRUITING
Yokosuka
Contact Information
Primary
Takayuki Warisawa, MD, PhD
warisawa-tky@umin.ac.jp
81-3-3448-6111
Time Frame
Start Date: 2024-05-27
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 280
Treatments
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.
Sponsors
Leads: TCROSS Co., Ltd.
Collaborators: Kaneka Corporation

This content was sourced from clinicaltrials.gov