de novo, calcified coronary artery lesions
Conditions
Interventions
investigational material(s)
Generic name etc : SWM-1234
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : To facilitate coronary
Sponsors
ShockWave Medical, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are required to meet all of the following inclusion criteria in order to be enrolled in this study. 1. Subject is >= 18 years of age 2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI 3. For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn, both must be normal) 4. For patients with stable ischemic heart disease:, biomarkers may be drawn prior to the index procedure or at the time of the procedure from the side port of the sheath. a. If drawn prior to the procedure, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the index procedure (note: if both labs are drawn, both must be normal) b. If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, results do not need to be analyzed prior to enrollment. 5. Left ventricular ejection fraction > 25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criteria; may be assessed at time of index procedure) 6. Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures 7. Lesions in non-target vessels requiring PCI may be treated either: a. >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or b. >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis normal; or c. >30 days after the study procedure Angiographic Inclusion Criteria 8. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure 9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with: a. Stenosis of >=70% and =50% and =2.5 mm and =270 degrees of calcium on at least 1 cross section 14. Ability to pass a 0.014'' guide wire across the lesion
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria will not be enrolled in this study: 1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits 2. Subject is a member of a vulnerable population as defined in 21 CFR 56.111, including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention 3. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint 4. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment) 5. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months 6. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated 7. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK-MB greater than 1 times the local laboratory' s upper limit of normal. 8. New York Heart Association (NYHA) class III or IV heart failure 9. Renal failure with serum creatinine >2.5 mg/dL, or chronic dialysis 10. History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit 11. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months 12. Untreated pre-procedural hemoglobin 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment) 14. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders 15. Uncontrolled diabetes defined as a HbA1c >= 10% 16. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics 17. Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia) 18. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg) 19. Subjects with a life expectancy of less than 1 year 20. Non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.) or surgical structural heart procedures within 30 days prior to the index procedure 21. Planned non-coronary interventional (e.g., TAVR, MitraClip, or PFO occlusion, etc.)or surgical structural heart procedures within 30 days after the index procedure 22. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery 23. Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy 24. Unprotected left main diameter stenosis >30% 25. Target vessel is excessively tortuous defined as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Primary Safety Endpoint: The primary safety endpoint is freedom from major adverse cardiac events (MACE) within 30 days of the index procedure. MACE is defined as the composite occurrence of: > Cardiac death; or > Myocardial Infarction (MI) defined as 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 using the Fourth Universal Definition of Myocardial Infarction beyond discharge (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 as the following: Procedural Success defined as stent delivery with a residual stenosis <50% (angiographic core laboratory assessed) and without in-hospital MACE. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Device Crossing Success is defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. Angiographic Success defined as stent delivery with <50% residual stenosis and without serious angiographic complications. Procedural Success defined as stent delivery with a residual stenosis <30% (core laboratory assessed) and without in-hospital MACE. Angiographic Success defined as stent delivery with <30% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. MACE at 6, 12 and 24 months. ? 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) by percutaneous or surgical methods at 30 days, 6, 12 and 24 months. 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 stent thrombosis (ARC definite, probable, definite or probable). Sensitivity analyses will be reported for MI using the Fourth Universal Definition of MI14 and the Society for Cardiovascular Angiography and Interventions (SCAI) 15 definitions at 30 days, 6, 12 and 24 months. | — |
Countries
Japan
Outcome results
None listed