None

Not yet recruiting

• Conditions: ischemic heart disease

• Registration Number: jRCT2032240612
• Lead Sponsor: Bio-heart Biological Technology Co., Ltd. (In Country Clinical Care-taker: CMIC Co., Ltd.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-16
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

Clinical Inclusion Criteria:

1. Subjects who are 18 years or older at the time of consent.
2. Subjects who are eligible for Percutaneous Coronary Intervention (PCI).
3. Subjects diagnosed with stable angina or unstable angina. In the case of stable angina, the patient must meet one of the following criteria:

1. Stenotic lesions with 90% or greater narrowing.
2. Stenotic lesions considered to be the cause of stable exertional angina (only if no other significant stenotic lesions are observed).
3. Stenotic lesions confirmed as the cause of functional ischemia through tests for the evaluation of functional ischemia. The evaluation of functional ischemia should use indices such as Fractional Flow Reserve (FFR) or resting coronary flow ratios (iFR, QFR, dPR, DFR, etc.).
   *Cut-off values for each index should be used as reference values.

4. Subjects who may be eligible for Coronary Artery Bypass Graft (CABG).
5. In the case of the instent restenosis sub-study (ISR sub-study), Subjects must have target lesions for initial or second treatment among in-stent restenosis lesions.
6. Subjects must be able to comply with all follow-up evaluations specified in the clinical trial protocol.
7. Subjects must understand the contents of the informed consent document and voluntarily agree in writing to participate in the clinical trial.

Angiographic Inclusion Criteria (Visual Assessment):

1. The target lesion must meet the following criteria:

1. Lesion length: 28 mm or less by visual assessment.
2. Reference vessel diameter: 2.00 mm or more and less than 3.00 mm for the small vessel study (SV study), and 2.00 mm or more and 4.00 mm or less for the ISR sub-study.
3. Diameter stenosis: 75% or more and less than 100%.
4. The coronary artery must be anatomically suitable for the delivery of the investigational device to the treatment site.
5. Successful pre-dilation has been achieved.

2. The number of lesions requiring treatment during the trial procedure should be within two branches and two lesions (the SV trial allows treatment of up to one branch and two lesions, while the ISR sub-study allows treatment of only one lesion per branch, with the investigational device targeting the primary lesion, and other lesions should be treated before the primary lesion as a rule).

Exclusion Criteria

Clinical Exclusion Criteria

1. Subjects who have experienced an acute myocardial infarction within 72 hours before the index procedure.
2. Subjects with cardiogenic shock, unstable hemodynamics requiring inotropic support or mechanical circulatory assistance, refractory ventricular arrhythmias, or progressive refractory angina.
3. Subjects with severe left ventricular dysfunction with an ejection fraction of less than 30%.
4. Subjects with a platelet count of less than 100,000/mm^3 or more than 700,000/mm^3.
5. Subjects with a white blood cell count of less than 3,000/mm^3.
6. Subjects with bleeding diathesis or coagulation disorders, or those who refuse blood transfusions.
7. Subjects who have experienced a cerebrovascular accident or transient ischemic attack within 6 months before the index procedure.
8. Subjects with active peptic ulcers or gastrointestinal bleeding.
9. Subjects with bleeding tendencies, contraindications to platelet products or anticoagulant therapy, or those unable to undergo anticoagulant therapy.
10. Subjects with a history of treatment using a drug-coated balloon (DCB) with sirolimus or paclitaxel within 10 mm of the target lesion. In the ISR sub-study, Subjects with a history of treatment using a DCB with sirolimus or paclitaxel on the target lesion are also excluded.
11. Subjects who have undergone PCI on the target vessel within 6 months before the index procedure.
12. Subjects requiring the use of laser, atherectomy, or debulking devices on the target vessel before treatment with the investigational device (during the index procedure).
13. Subjects who have non-target vessels treated with any type of PCI within 24 hours before the index procedure.
14. Subjects planning to undergo PCI (including staged PCI) or CABG within 6 months after the index procedure.
15. Subjects planning surgery requiring the cessation of dual antiplatelet therapy within 3 months.
16. Subjects with renal failure with serum creatinine levels exceeding 2.0 mg/dl or those undergoing dialysis.
17. Subjects with clinically severe liver disease or suspected severe liver disease.
18. Subjects with known allergies or hypersensitivity to paclitaxel, sirolimus and its structural analogs (biolimus A9, everolimus, zotarolimus, etc.), iopromide, or materials used in the investigational device.
19. Subjects with known allergies or hypersensitivity to contrast agents.
20. Subjects with hypersensitivity to polylactic acid, polycaprolactone, or their structural analogs.
21. Subjects with a history of organ transplantation or those planning to undergo organ transplantation.
22. Subjects who have received or are planning to receive cancer chemotherapy within 30 days before the index procedure.
23. Subjects participating in other clinical trials of drugs or medical devices who have not yet reached the primary endpoint.
24. Pregnant or breastfeeding women, or women planning to become pregnant within 6 months after the procedure.
25. Subjects with other serious diseases (e.g., cancer, congestive heart failure) with an expected survival of less than 12 months.
26. Subjects with complications that prevent compliance with the clinical trial protocol requirements or those deemed inappropriate for trial participation by the investigator for any reason.

Angiographic Exclusion Criteria (Visual Assessment):

1. If the target lesion meets any of the following criteria

1. Lesion in the left main coronary artery.
2. Lesion within 5 mm of the ostium of the left anterior descending artery or left circumflex artery.
3. Lesion with diameter stenosis exceeding 50% within 10 mm proximal or distal to the target lesion.
4. Lesion within an arterial graft or saphenous vein graft.
5. Lesion requiring access through an arterial graft or saphenous vein graft to reach the target lesion.
6. Complex bifurcation lesion requiring complex procedures (e.g., requiring treatment with two or more stents).
7. Lesion with TIMI flow 0 (complete occlusion) before guidewire crossing.
8. Lesion with excessive tortuosity proximal or distal to the target lesion.
9. Lesion with excessive angulation proximal or distal to the target lesion.
10. Lesion with severe calcification by visible estimate in the target vessel proximal or distal to the target lesion, potentially resulting in suboptimal expansion.
11. Lesion with dissection or aneurysm visible by eye in the target vessel adjacent to the target lesion.
12. Restenotic lesion after PCI (SV trial only).
13. PCI performed within 10 mm proximal or distal to the target lesion before the index procedure (SV trial only).
14. Treatment requiring two or more investigational devices for one target lesion.
15. In-stent restenosis lesion due to stent fracture or recoil (ISR sub-study only).

2. If non-target lesions treated during the index procedure meet any of the following criteria:

1. Located in the target vessel (ISR sub-study only).
2. Lesion within a bypass graft.
3. Lesion in the left main coronary artery.
4. Chronic total occlusion.
5. Complex bifurcation lesion requiring complex procedures (e.g., requiring treatment with two or more stents).
6. Severely calcified lesion requiring debulking devices.
7. Lesion within 15 mm proximal or distal to the target lesion (applies only when treating non-target lesions located in the target vessel in the SV trial).

3. If there are two or more treatment target lesions that meet all inclusion criteria and do not conflict with exclusion criteria, exclusion is applied as the target lesion cannot be determined.
4. Lesion with diameter stenosis exceeding 50% in the unprotected left main coronary artery.
5. Presence or potential presence of thrombus in the target vessel.
6. History of coronary spasm.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Target Lesion Failure (TLF) rate at 6 months after the index-procedure

Secondary Outcome Measures

Name	Time	Method
Seattle Angina Questionnaire 7-item version (SAQ-7)	before the index procedure, and at 6 months, 12 months, 24 months, and 36 months after the index procedure	Evaluate patient-reported outcomes (PRO) using the disease-specific Seattle Angina Questionnaire 7-item version (SAQ-7) for patients with Coronary Artery Disease (CAD)