Coronary Artery Disease Coronary Artery Disease, DCB, IVL
Conditions
Interventions
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
Sponsors
Kozuma Ken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 lab normal, biomarker result must be less than 5 times the upper limit of lab normal within 12 hours prior to the procedure 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. Lesions in non-target vessels (prior to index) requiring PCI or CABG must be treated >30 days prior to the study procedure. If the following criteria is met, non-target lesions (NTL) may be treated during the index procedure: A maximum of two NTL may be treated during the index procedure. a. 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. Intravascular imaging must be performed in all NTL without serious angiographic complications in any NTL at final view i.e. at final view after stenting there are no flow limiting dissections (grade C or above), no perforations, no slow flow, and no evidence of no reflow Angiographic Inclusion Criteria 7. The target lesion must be a de novo coronary lesion (i.e. a lesion that has not been previously treated with any interventional procedure including POBA and DCB) 8. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with: a. Stenosis of 70% or more and <100% or b. Stenosis 50% or more and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value 0.80 or less, or iFR <0.90 9. The target vessel reference diameter must be 2.5 mm or more and 4.0 mm or less 10. The lesion length must not exceed 30mm 11. The target vessel must have TIMI flow 3 at baseline (visually assessed, may be assessed after pre-dilatation) 12. Ability to pass a 0.014" guide wire across the lesion Imaging Inclusion Criteria 13. Evidence of calcification at the lesion site by OCT/OFDI, with a calcium scoring of at least 3 points (severe calcification), according to the CVIT Consensus on calcium scoring.
Exclusion criteria
Exclusion 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. Unable to tolerate anticoagulation/ antiplatelet therapy per Japanese circulation 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 180 mmHg or diastolic blood pressure >110 mmHg) 16. Have been diagnosed with less than one year left to live 17. Non-coronary interventional (e.g., TAVR, TEER, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure 18. Planned non-coronary interventional (e.g., TAVR, TEER or PFO occlusion, etc.) or surgical structural heart procedures within 30 days after the index procedure 19. Refusing or not eligible for emergency coronary artery bypass grafting (CABG) 20. Planned use of advanced plaque modification tools including cutting balloon, laser, or any device other than IVL to the target lesion, with the exception of standard semi-compliant or non-compliant balloons Angiographic Exclusion Criteria 21. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel 22. Evidence of aneurysm in target vessel within 10 mm of the target lesion 23. Target lesion is in an aorto-ostial (RCA and LMT ostium lesion) or an unprotected left main location 24. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft 25. Previous stent within 5 mm of the target lesion regardless of the timing of its implantation 26. Angiographic evidence of a dissection (Type C-F) in the target vessel at baseline or after guidewire passage 27. Failure to successfully treat significant non-target coronary lesions. Successful treatment is defined as obtaining 50% or less residual stenosis with no serious angiographic complications (example is embolism)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint Safety will be assessed by freedom from major adverse cardiac events (MACE) within 30 days of the index procedure. MACE is defined as: - Cardiac death; or - Myocardial Infarction (per SCAI definition of periprocedural MI; per 4th Universal definition for spontaneous MI); or - Target Vessel Revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure Primary Effectiveness Endpoint The primary effectiveness endpoint will be evaluated on a procedural/subject level as the following: Procedural Success defined as final residual stenosis post DCB (or bailout stenting) of <50% (angiographic core laboratory assessed) and without in-hospital MACE (CEC adjudicated) | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 (CEC adjudicated) (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. (CEC adjudicated) (8) At each time period: All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and lesion thrombosis (including stent thrombosis) (ARC definite, probable, definite or probable). (CEC adjudicated) (9) Sensitivity analyses will be reported for MI using alternative definitions: 1.) Fourth Universal definition of MI for periprocedural MI associated with PCI and Spontaneous MI, and 2.) CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave at discharge (periprocedural MI) and Fourth Universal definition of MI.(CEC adjudicated) (10) Site-reported BARC (Bleeding Academic Research Consortium) 3-5 Bleeding at 30 days, 6 and 12 months. (CEC adjudicated) | — |
Contacts
Public ContactKen Kozuma
Teikyo University Hospital
Outcome results
None listed