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

Stable Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436092
• Other study ID #: JDEPTH-LM Registry
• Secondary ID: jRCT1030240071
• Status: Recruiting
• Start date: May 27, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: May 2024
• Source: TCROSS Co., Ltd.
• Contact: Takayuki Warisawa, MD
• Phone: 81-3-3448-6111
• Email: warisawa-tky[@]umin.ac.jp
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 31, 2029
• Est. primary completion date: May 31, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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) 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Non-ST-elevation Acute Coronary Syndrome
• Stable Angina
• Unstable Angina

Locations

Country	Name	City	State
Japan	Sakakibara Heart Institute	Fuchu	Tokyo
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Gifu Heart Center	Gifu
Japan	Hakodate Municipal Hospital	Hakodate	Hokkaido
Japan	Ichinomiya Municipal Hospital	Ichinomiya	Aichi
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Kanazawa Cardiovascular Hospital	Kanazawa	Ishikawa
Japan	Chikamori Hospital	Kochi
Japan	Kumamoto University Hospital	Kumamoto
Japan	New Tokyo Hospital	Matsudo	Chiba
Japan	Ehime Prefectural Central Hospital	Matsuyama	Ehime
Japan	NTT Medical Center Tokyo	Shinagawa	Tokyo
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura	Ibaraki
Japan	Tsukuba Medical Center Hospital	Tsukuba	Ibaraki
Japan	Urasoe General Hospital	Urasoe	Okinawa
Japan	Japanese Red Cross Wakayama Medical Center	Wakayama
Japan	Yokosuka Kyosai Hospital	Yokosuka	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
TCROSS Co., Ltd.	Kaneka Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	During PCI procedure
Other	ST-change recovery time	confirming that ECG changes can easily recover even after W-KBT for LMD	During PCI procedure
Other	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
Other	Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS)		During PCI procedure
Other	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
Other	Incidence of symptom onset during W-KBT and reviewing cases showing these symptoms		During PCI procedure
Other	Incidence of Treatment Adverse Events [Safety and Tolerability] in patients with low left ventricular ejection fraction (LVEF)	The incidence rate will be calculated using the median LVEF or 40% as the cutoff	During PCI procedure & Within 12 months of PCI
Other	The procedural success rate based on the number of LM-PCI experiences	comparing efficacy and safety among various groups based on PCI operators' experience	During PCI procedure & Within 12 months of PCI
Other	Late lumen loss	in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)	During PCI procedure & Within 12 months of PCI
Other	Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit		Within 12 months of PCI
Primary	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	During PCI procedure
Primary	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	Within 12 months of PCI procedure
Secondary	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	During PCI procedure
Secondary	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	During PCI procedure
Secondary	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)	During PCI procedure
Secondary	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	During PCI procedure
Secondary	Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium	confirming the frequency of occurrences for each component of MACE	Within 12 months of PCI