NCT06436092

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 280 (estimated)
• Sponsor: TCROSS Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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.

Conditions

• Stable Angina
• Non-ST-elevation Acute Coronary Syndrome
• Unstable Angina

Timeline

• Start date: 2024-05-27
• Primary completion: 2027-05-31
• Completion: 2029-12-31
• First posted: 2024-05-30
• Last updated: 2025-03-13

Locations

32 sites across 1 country: Japan