Non-ST-elevation Acute Coronary Syndrome, Stable Angina, Unstable Angina
Conditions
Keywords
Ischemic heart disease
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.
Interventions
None listed
Sponsors
Kaneka Corporation
TCROSS Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. Age ≥ 18 years 2. Patient with stable coronary artery disease, non-ST-elevation myocardial infarction, or unstable angina 3. Left main disease confirmed by coronary angiography or coronary CT angiography 4. Clinical and anatomical eligibility for PCI as agreed by the local Heart Team 5. Patient with consent prior to undergoing PCI 6. Left main Medina classification (1,1,1), (1,0,1), (0,1,1), (0,0,1) confirmed by coronary angiography 7. De novo target lesion in LMT-LAD amenable for crossover stenting with provisional side-branch approach as determined by PCI operator 8. De novo ostial LCx lesions 9. Lesion indicated in No. 8 with a length of less than 10 mm or a stenosis of less than 70% confirmed by coronary angiography
Exclusion criteria
1. Inability to provide written informed consent 2. Patient with a history of ST-elevation myocardial infarction within the previous 1 week 3. Patient in a state of cardiogenic shock 4. Patient with a history of coronary artery bypass grafting 5. Patient with malignant tumors or other conditions with a life expectancy of less than one year 6. Patient considered suitable for stent placement in the ostial LCx from a medical perspective 7. Patient considered unsuitable for anti-thrombotic therapy after PCI 8. Other patient whom the investigator deems unsuitable for the safe conduct of LM-PCI, including W-KBT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success rate | During PCI procedure | 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 |
| Major adverse cardiovascular event (MACE) at 12 months | Within 12 months of PCI procedure | consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum changes in blood pressure and heart rate | During PCI procedure | 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 to ST-change from DCB inflation | During PCI procedure | 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 |
| Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium | Within 12 months of PCI | confirming the frequency of occurrences for each component of MACE |
| Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT | During PCI procedure | confirming that hemodynamics is not disturbed by W-KBT for LMD |
| Total DCB Inflation time | During PCI procedure | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| The procedural success rate based on the number of LM-PCI experiences | During PCI procedure & Within 12 months of PCI | comparing efficacy and safety among various groups based on PCI operators' experience |
| Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT | During PCI procedure | Fractional flow reserve (FFR) values will be measured before and after each KBT, using either a conventional balloon or PB |
| Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit | Within 12 months of PCI | — |
| Late lumen loss | During PCI procedure & Within 12 months of PCI | in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography) |
| ST-change recovery time | During PCI procedure | confirming that ECG changes can easily recover even after W-KBT for LMD |
| 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 | Within 12 months of PCI | — |
| Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS) | During PCI procedure | — |
| MACE at 12 months based on lesion characteristics at the LCx ostial lesions and the type of lesion preparation step | Within 12 months of PCI | — |
| Incidence of symptom onset during W-KBT and reviewing cases showing these symptoms | During PCI procedure | — |
| Incidence of Treatment Adverse Events [Safety and Tolerability] in patients with low left ventricular ejection fraction (LVEF) | During PCI procedure & Within 12 months of PCI | The incidence rate will be calculated using the median LVEF or 40% as the cutoff |
Countries
Japan
Contacts
Primary ContactTakayuki Warisawa, MD, PhD
Outcome results
None listed