## Protocol Section
### Identification Module
**NCT ID:** NCT06436092

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

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

#### Organization Study ID Info
**ID:** JDEPTH-LM Registry
#### Organization
**Class:** INDUSTRY
**Full Name:** TCROSS Co., Ltd.
#### Secondary ID Infos
**Domain:** Japan Registry of Clinical Trials
**ID:** jRCT1030240071
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2029-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-27

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Kaneka Corporation

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** TCROSS Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Stable Angina

- Non-ST-elevation Acute Coronary Syndrome

- Unstable Angina

**Keywords:**

- Ischemic heart disease

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 280

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 12 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Label:** JDEPTH-LM Registry Participants

### Outcomes Module

#### Other Outcomes

**Description:** Fractional flow reserve (FFR) values will be measured before and after each KBT, using either a conventional balloon or PB

**Measure:** Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT

**Time Frame:** During PCI procedure

**Description:** confirming that ECG changes can easily recover even after W-KBT for LMD

**Measure:** ST-change recovery time

**Time Frame:** During PCI procedure

**Measure:** 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 PCI

**Measure:** Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS)

**Time Frame:** During PCI procedure

**Measure:** MACE at 12 months based on lesion characteristics at the LCx ostial lesions and the type of lesion preparation step

**Time Frame:** Within 12 months of PCI

**Measure:** Incidence of symptom onset during W-KBT and reviewing cases showing these symptoms

**Time Frame:** During PCI procedure

**Description:** The incidence rate will be calculated using the median LVEF or 40% as the cutoff

**Measure:** Incidence of Treatment Adverse Events [Safety and Tolerability] in patients with low left ventricular ejection fraction (LVEF)

**Time Frame:** During PCI procedure & Within 12 months of PCI

**Description:** comparing efficacy and safety among various groups based on PCI operators' experience

**Measure:** The procedural success rate based on the number of LM-PCI experiences

**Time Frame:** During PCI procedure & Within 12 months of PCI

**Description:** in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)

**Measure:** Late lumen loss

**Time Frame:** During PCI procedure & Within 12 months of PCI

**Measure:** Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit

**Time Frame:** Within 12 months of PCI

#### Primary Outcomes

**Description:** 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

**Measure:** Procedure success rate

**Time Frame:** During PCI procedure

**Description:** consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease

**Measure:** Major adverse cardiovascular event (MACE) at 12 months

**Time Frame:** Within 12 months of PCI procedure

#### Secondary Outcomes

**Description:** 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

**Measure:** Time to ST-change from DCB inflation

**Time Frame:** During PCI procedure

**Description:** 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

**Measure:** Total DCB Inflation time

**Time Frame:** During PCI procedure

**Description:** 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)

**Measure:** Maximum changes in blood pressure and heart rate

**Time Frame:** During PCI procedure

**Description:** confirming that hemodynamics is not disturbed by W-KBT for LMD

**Measure:** Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT

**Time Frame:** During PCI procedure

**Description:** confirming the frequency of occurrences for each component of MACE

**Measure:** Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium

**Time Frame:** Within 12 months of PCI

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** warisawa-tky@umin.ac.jp

**Name:** Takayuki Warisawa, MD

**Phone:** 81-3-3448-6111

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ichinomiya

**Contacts:**

***Contact 1:***

- **Name:** Hisaaki Ishiguro

- **Role:** CONTACT

**Country:** Japan

**Facility:** Ichinomiya Municipal Hospital

**State:** Aichi

**Status:** NOT_YET_RECRUITING

**Location 2:**

**City:** Matsudo

**Contacts:**

***Contact 1:***

- **Name:** Koji Hozawa

- **Role:** CONTACT

**Country:** Japan

**Facility:** New Tokyo Hospital

**State:** Chiba

**Status:** NOT_YET_RECRUITING

**Location 3:**

**City:** Matsuyama

**Contacts:**

***Contact 1:***

- **Name:** Hideki Okayama

- **Role:** CONTACT

**Country:** Japan

**Facility:** Ehime Prefectural Central Hospital

**State:** Ehime

**Status:** RECRUITING

**Location 4:**

**City:** Hakodate

**Contacts:**

***Contact 1:***

- **Name:** Yusuke Tokuda

- **Role:** CONTACT

**Country:** Japan

**Facility:** Hakodate Municipal Hospital

**State:** Hokkaido

**Status:** NOT_YET_RECRUITING

**Location 5:**

**City:** Tsuchiura

**Contacts:**

***Contact 1:***

- **Name:** Tsunekazu Kakuta

- **Role:** CONTACT

**Country:** Japan

**Facility:** Tsuchiura Kyodo General Hospital

**State:** Ibaraki

**Status:** RECRUITING

**Location 6:**

**City:** Tsukuba

**Contacts:**

***Contact 1:***

- **Name:** Hidetaka Nishina

- **Role:** CONTACT

**Country:** Japan

**Facility:** Tsukuba Medical Center Hospital

**State:** Ibaraki

**Status:** NOT_YET_RECRUITING

**Location 7:**

**City:** Kanazawa

**Contacts:**

***Contact 1:***

- **Name:** Hidenobu Terai

- **Role:** CONTACT

**Country:** Japan

**Facility:** Kanazawa Cardiovascular Hospital

**State:** Ishikawa

**Status:** RECRUITING

**Location 8:**

**City:** Kamakura

**Contacts:**

***Contact 1:***

- **Name:** Koki Shishido

- **Role:** CONTACT

**Country:** Japan

**Facility:** Shonan Kamakura General Hospital

**State:** Kanagawa

**Status:** RECRUITING

**Location 9:**

**City:** Yokosuka

**Contacts:**

***Contact 1:***

- **Name:** Tadashi Murai

- **Role:** CONTACT

**Country:** Japan

**Facility:** Yokosuka Kyosai Hospital

**State:** Kanagawa

**Status:** RECRUITING

**Location 10:**

**City:** Urasoe

**Contacts:**

***Contact 1:***

- **Name:** Hiroki Uehara

- **Role:** CONTACT

**Country:** Japan

**Facility:** Urasoe General Hospital

**State:** Okinawa

**Status:** RECRUITING

**Location 11:**

**City:** Fuchu

**Contacts:**

***Contact 1:***

- **Name:** Kenichi Hagiya

- **Role:** CONTACT

**Country:** Japan

**Facility:** Sakakibara Heart Institute

**State:** Tokyo

**Status:** NOT_YET_RECRUITING

**Location 12:**

**City:** Shinagawa

**Contacts:**

***Contact 1:***

- **Name:** Takayuki Warisawa

- **Role:** CONTACT

**Country:** Japan

**Facility:** NTT Medical Center Tokyo

**State:** Tokyo

**Status:** RECRUITING

**Location 13:**

**City:** Fukuoka

**Contacts:**

***Contact 1:***

- **Name:** Yoshinobu Murasato

- **Role:** CONTACT

**Country:** Japan

**Facility:** National Hospital Organization Kyushu Medical Center

**Status:** NOT_YET_RECRUITING

**Location 14:**

**City:** Gifu

**Contacts:**

***Contact 1:***

- **Name:** Yoshiaki Kawase

- **Role:** CONTACT

**Country:** Japan

**Facility:** Gifu Heart Center

**Status:** RECRUITING

**Location 15:**

**City:** Kochi

**Contacts:**

***Contact 1:***

- **Name:** Ryu-Ichirou Imai

- **Role:** CONTACT

**Country:** Japan

**Facility:** Chikamori Hospital

**Status:** NOT_YET_RECRUITING

**Location 16:**

**City:** Kumamoto

**Contacts:**

***Contact 1:***

- **Name:** Kenichi Tsujita

- **Role:** CONTACT

**Country:** Japan

**Facility:** Kumamoto University Hospital

**Status:** NOT_YET_RECRUITING

**Location 17:**

**City:** Wakayama

**Contacts:**

***Contact 1:***

- **Name:** Junichi Tazaki

- **Role:** CONTACT

**Country:** Japan

**Facility:** Japanese Red Cross Wakayama Medical Center

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002637

- Term: Chest Pain

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000003327

- Term: Coronary Disease

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Left Main Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M27545

- Name: Acute Coronary Syndrome

- Relevance: HIGH

- As Found: Acute Coronary Syndrome

- ID: M4117

- Name: Angina Pectoris

- Relevance: HIGH

- As Found: Angina

- ID: M29575

- Name: Angina, Stable

- Relevance: HIGH

- As Found: Stable Angina

- ID: M4119

- Name: Angina, Unstable

- Relevance: HIGH

- As Found: Unstable Angina

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M5882

- Name: Chest Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000054058

- Term: Acute Coronary Syndrome

- ID: D000000787

- Term: Angina Pectoris

- ID: D000060050

- Term: Angina, Stable

- ID: D000000789

- Term: Angina, Unstable

- ID: D000003324

- Term: Coronary Artery Disease

### Misc Info Module

- Version Holder: 2024-05-31
