coronary artery stenose shockwave and balloon theraphy
Conditions
Sponsors
Bolt Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age of subject is >=18. 2. Subjects with native coronary artery disease (including stable or unstable angina, or 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. o 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 of the procedure (note: if both labs are drawn, both must be normal). o 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 (note: CK-MB is required if drawn from the sheath). 5. Left ventricular ejection fraction (LVEF) >25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criterion; 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: o >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or o >24 hours prior to the study procedure if the procedure was successful and without complications (defined as a final lesion angiographic diameter stenosis normal); or o >30 days after the study procedure Angiographic Inclusion Criteria 1. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure 2. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with: o Stenosis of >70% and 50% and 2.5 mm and 270 degrees of calcium on at least 1 cross section 7. Ability to pass a 0.014* guide wi
Exclusion criteria
Exclusion criteria: 1. Any comorbidity or condition which may reduce compliance with the 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 (for patients not on oral anticoagulation) 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 at time of index procedure 9. Renal failure with serum creatinine >2.5 mg/dL, GFR 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 > l0% 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 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 or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure 21. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) 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, Shockwave lithotripsy d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: The primary safety endpoint is freedom from major adverse cardiac events (MACE) within 30 days following the index procedure. MACE is defined as the occurrence of cardiac death, MI or TVR. • Myocardial Infarction (MI) is defined as CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave 12 to 24 hours post procedure or at discharge (periprocedural MI) and by the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI) • Target Vessel Revascularization (TVR) is defined as revascularization at the target vessel (including the target lesion) after completion of the index procedure. Effectiveness: The primary effectiveness endpoint is the rate of procedural success defined as successful stent delivery with a residual stenosis | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. Device crossing success defined as the ability to deliver the IVL catheter across the target lesion and delivery of lithotripsy without serious angiographic complications immediately after IVL. 2. Angiographic success defined as stent delivery with | — |
Countries
Netherlands
Outcome results
None listed