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:
TCROSS Co., Ltd.
Organization:
Study Overview
Official Title:
Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| jRCT1030240071 | OTHER | Japan Registry of Clinical Trials | View |