Post-market, Prospective, Multicenter, Single-Arm Study of C2 Coronary IVL System in Calcified Coronary Artery Lesions prior to Drug-Coated Balloon Angioplasty in Japan

JRCT ID: jRCTs032240483

Registered date:13/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Coronary Artery Disease
• Date of first enrollment: 13/11/2024
• Target sample size: 200
• Study type: Interventional
• Intervention(s): In patients with coronary artery disease who are eligible for non-urgent PCI, IVL is performed as pretreatment for DCB for new coronary lesions with a target vessel diameter of 2.5mm to 4.0mm, lesion length of 30mm or less, and severe calcification confirmed by OCT/OFDI. After pretreatment with IVL, DCB or bailout stent placement is performed according to the CVIT (Japanese Society of Cardiovascular Intervention and Therapeutics) consensus document on DCB for coronary artery disease.

Outcome(s)

Primary Outcome

- Primary safety endpoint
Safety will be evaluated as the rate of non-occurrence of major adverse cardiovascular events (MACE) within 30 days after the procedure. MACE will be defined as the composite occurrence of the following events and will be assessed by the Clinical Event Adjudication Committee (CEC):
- Primary efficacy endpoint
The primary efficacy endpoint will be assessed at the procedure and study subject level as follows:
Procedural success defined as a final residual stenosis of <50% after DCB (+- bail-out stent) (angiographic core lab assessment) and no MACE (Clinical Events Committee assessment) during hospitalization

Secondary Outcome

(1) Successful IVL device delivery: defined as successful delivery of a C2 coronary IVL catheter to the target lesion and the absence of any serious angiographic complications immediately after treatment.
(2) Angiographic success: defined as residual stenosis below 30% and no angiographic complications (angiographic core laboratory assessment).
(3) Angiographic success: defined as less than 50% residual stenosis and no angiographic complications (angiographic core laboratory assessment).
(4) Procedural success: defined as residual stenosis below 30% (core laboratory assessment) and no occurrence of MACE during hospitalization
(5) Severe angiographic complications: defined as severe dissection (Type C-F), perforation, acute occlusion, persistent slow flow, or persistent no reflow after IVL and at the last imaging time point (angiography core lab assessment).
(6) MACE at 6 and 12 months
(7) Target lesion failure (TLF): defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) using percutaneous or surgical procedures at 30 days, 6 months, or 12 months.
(8) All-cause mortality, cardiac death, MI, TV-MI, procedural MI and non-procedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definition: "definite," "probable," or "definite or probable") in each period.
(9) Sensitivity analyses using the Fourth Universal definition of MI and an alternative definition of MI with CK-MB >3x the upper limit of the facility reference range were reported at 30 days, 6 months, and 12 months.
(10) BARC (Bleeding Academic Research Consortium) bleeding criteria Type 3-5 at 30 days, 6 months, and 12 months as reported by the institution.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age 18 or older
2. Patients with stable angina or de novo coronary lesions suitable for non-urgent percutaneous coronary intervention (PCI) following stabilization of unstable angina or NSTEMI
3. In patients not undergoing a scheduled or elective procedure with stable angina, the myocardial ischemia biomarker troponin is.
a. Test values within 12 hours prior to the procedure are below the upper limit of normal range at the medical institution.
or,
b. If above the upper limit of the facility's reference range, biomarker results within 12 hours prior to the procedure must be 5x or less than the upper limit of the facility's reference range and the following criteria must be met.
The procedure was elective and not urgent, and study participants did not have angina at rest
4. Left ventricular ejection fraction of 25% or more within 6 months (Note. If LVEF is evaluated multiple times, the measurement closest to registration will be used. It can also be evaluated at the time of the procedure.)
5. The patient or legally authorized representative has signed an informed consent form for participation in this study prior to any procedures prescribed by the study.
6. Non-target vascular lesions requiring PCI or CABG must have been treated within 30 days prior to the study procedure. However, if the following criteria are met, non-target lesions may be treated during the study procedure. Note that up to two non-target lesions may be treated during the study procedure.
All non-target lesions must be performed prior to target lesion treatment and must not be in the same vessel as the target vessel.
b. All non-target lesions must be treated with DES. in non-target lesions, DES must be appropriately placed. DCBs should not be used in non-target lesions.
c. Imaging diagnosis was performed on all non-target lesions using imaging devices, and it was confirmed that there were no serious angiographic complications (the final angiogram after stent placement showed no severe dissection (grade D or higher) that blocks blood flow, perforation, slow flow, or no reflow).

Exclude criteria

1. Have comorbidities or conditions that may prevent adherence to the protocol, including follow up visits
2. Patients who are participating or may participate in other studies using other investigational products (drugs, biological products, or medical devices) that have not reached the primary endpoint or that may affect this study
3. Pregnant or breastfeeding
4. Inability to tolerate anticoagulant/antiplatelet therapy as prescribed by the society guidelines
5. I have an allergy to contrast media and cannot use the medication properly.
6. STEMI within 30 days prior to the procedure
7. New York Heart Association (NYHA) Class III or IV heart failure
8. Renal failure with serum creatinine level above 2.5 mg/dL or chronic dialysis patient
9. History of stroke or transient ischemic attack (TIA) within 60 days, or previous intracranial hemorrhage or persistent neurological disorder
10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the past 3 months
11. Pre procedure hemoglobin level <10 g/dL and untreated or willing to refuse blood transfusion if required
12. Patients with hypercoagulable disorders such as coagulation disorders with platelet counts less than 100,000,000/ml or more than 750,000, polycythemia vera, or other disorders
13. Have fever or leukocytosis or active systemic infection requiring intravenous antibiotics on the day of the procedure
14. There is clinical evidence of cardiogenic shock
15. Poorly controlled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
16. Have been diagnosed with less than one year left to live
17. Have undergone a non-coronary interventional procedure (e.g., TAVR, MitraClip, or PFO closure) or structural heart surgery within 30 days prior to the procedure
18. Planned non coronary interventional procedures (e.g., TAVR, MitraClip, or PFO closure) or surgery for structural heart disease within 30 days of the procedure
19. Refusing or not eligible for emergency coronary artery bypass grafting (CABG)
20. The use of atherectomy, cutting balloon, laser, or plaque modification devices other than IVL is planned (excluding standard semi compliant, non-compliant balloons, or scoring balloons)

Related Information

• Primary Sponsor: Kozuma Ken
• Source(s) of Monetary Support: Shockwave Medical Inc.