Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436092
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-10
Brief Title:
Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease JDEPTH-LM Registry
Sponsor:
TCROSS Co Ltd
Organization:
TCROSS Co Ltd
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:
2024-05
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:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT1030240071 | OTHER | Japan Registry of Clinical Trials | None |