Coronary artery stenose shockwave and PTA Coronary artery stenose shockwave and PTA
Conditions
Sponsors
Bolt Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is >=18 years of age; 2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for Percutaneous Coronary Intervention (PCI); 3. For patients with unstable ischemic heart disease, a local site-based biomarker (preferably troponin or hs-troponin) must be less than or equal to the upper limit of lab normal (ULN) within 12 hours prior to the study procedure; 4. For patients with stable ischemic heart disease, CK-MB will be drawn at the time of the study procedure from the side port of the sheath; results need not be analyzed prior to enrollment, but must be less than or equal to the upper limit of lab normal (ULN); 5. Left ventricular ejection fraction (LVEF) >25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement obtained 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 30 days after the study procedure. 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
Exclusion criteria
Exclusion criteria: Exclusion Criteria: A potential study subject who meets any of the following exclusion criteria will be excluded: 1. Any comorbidity or condition which may reduce compliance with the protocol, including follow-up visits. 2. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment). 4. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 3 months (for patients not on oral anticoagulation). 5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated. 6. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure. 7. New York Heart Association (NYHA) class III or IV heart failure at time of index procedure. 8. Prospective need for hemodynamic support i.e., IABP or Impella 9. Chronic kidney disease with serum creatinine >2.5 mg/dL, eGFR 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. 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 closure, 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 closure, 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 device, or any investigational device other than the study device. 24. High SYNTAX Score (>= 33) if assessed as standard of care, unless the local heart team has met and recommends PCI is the most appropriate treatment for the patient. Angiographic Angiographic Exclusion Criteria 1. Unprotected left main diameter stenosis >50%. 2. Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º. 3. Definite or possible thrombus (by an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: The study*s 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, Myocardial Infarction (MI), or Target Vessel Revascularization (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 >=6 to 24 hours post-procedure (periprocedural MI), and by the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI). • Target Vessel Revascularization (TVR) is defined as revascularization of the target vessel (including the target lesion) after completion of the index procedure. Effectiveness: The study*s primary effectiveness endpoint is procedural success defined as successful stent delivery with a final residual stenosis | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. Device success defined as the ability to deliver the Bolt 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
Belgium, Denmark, Germany, Lithuania, Netherlands, United Kingdom, United States
Contacts
Public ContactT. E. Meyer
Bolt Medical, Inc.
Outcome results
None listed