Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTCROSS Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to provide written informed consent
Patient with a history of ST-elevation myocardial infarction within the previous 1 week
Patient in a state of cardiogenic shock
Patient with a history of coronary artery bypass grafting
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
280 Participants
are grouped into 1 trial groupGroup A: JDEPTH-LM Registry Participants
Trial outcomes
Primary outcomes
1
Procedure success rate
indicating the proportion of cases meeting the following three conditions: * Device delivery success * Achievement of DCB expansion for 30 seconds or more * No bailout stenting performed in the LCx
Time frame
During PCI procedure2
Major adverse cardiovascular event (MACE) at 12 months
consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease
Time frame
Within 12 months of PCI procedureSecondary outcomes
1
Time to ST-change from DCB inflation
confirming the time from the initiation of W-KBT to any ST elevation/depression in the electrocardiogram (ECG) to evaluate the safety of the procedure
Time frame
During PCI procedure2
Total DCB Inflation time
confirming the duration for which the inflation of the DCB can be sustained during W-KBT, as the recommendation time of DCB inflation is at least 30 seconds
Time frame
During PCI procedure3
Maximum changes in blood pressure and heart rate
confirming the extent of blood pressure and heart rate changes resulting from maintaining W-KBT for 30 seconds or longer in the left main coronary trunk (LMT)
Time frame
During PCI procedure4
Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT
confirming that hemodynamics is not disturbed by W-KBT for LMD
Time frame
During PCI procedureOther outcomes
1
Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT
Fractional flow reserve (FFR) values will be measured before and after each KBT, using either a conventional balloon or PB
Time frame
During PCI procedure2
ST-change recovery time
confirming that ECG changes can easily recover even after W-KBT for LMD
Time frame
During PCI procedure3
Incidence of periprocedural MI defined by Fourth Universal Definition of Myocardial Infarction (4th UDMI), Academic Research Consortium (ARC)-2 and Society for Cardiovascular Angiography and Interventions (SCAI) definitions
Time frame
Within 12 months of PCI4
Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS)
Time frame
During PCI procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
TCROSS Co., Ltd.
Lead sponsor
Kaneka Corporation
Collaborator
Source ClinicalTrials.gov