Health Condition 1: I258- Other forms of chronic ischemic heart disease
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is >=18 years of age. 2. Patients with calcified coronary artery disease requiring percutaneous revascularization plus stent implantation based on the hospital routine clinical practice and at the operatorâ??s discretion require an IVL using the Shockwave catheter. 3. For patients with unstable ischemic heart disease, biomarker (CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure. 4. For patients with stable ischemic heart disease, biomarker may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath: a. If drawn prior to the procedure, biomarker (CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours of the procedure. b. If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analysed prior to enrolment (note: CK-MB is required if drawn from the sheath). 5. Left ventricular ejection fraction >25% with ECHO within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrolment 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: 8. >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or 9. >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis normal; or 10. >30 days after the study procedure. Angiographic Inclusion Criteria 1. Patients with severely calcified coronary artery stenosis considered for PCI by Intervention Cardiologist (all comerâ??s population). 2. Single vessel target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches), if needed other vessels can be treated. 3. Evidence of calcification at the lesion site by: 4. angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT.
Exclusion criteria
Exclusion criteria: 1. All usual contraindications of angioplasty criteria and any comorbidity or condition which may reduce compliance for performing PCI. 2. Participant participating in another research study/registry involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary data point. 3. Participant is pregnant or nursing (Declaration will be given by female participant). 4. Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for participants not on oral anticoagulation). 5. Hemodynamic instability with Killip class III or IV. 6. Participants with a life expectancy of less than 1 year. 7. Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis. 8. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, Mitra Clip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure. 9. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, Mitra Clip, LAA or PFO occlusion, etc.) within 30 days after the index procedure. 10. Participant refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Safety will be assessed by freedom from major adverse cardiac events (MACE) within 30 days of the index procedure. 2.MACE is defined as: â?¢Cardiac death; or â?¢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 during the hospital stay before discharge (periprocedural MI) and using the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI); or â?¢Target Vessel Revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure Timepoint: 30 days of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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. 2. Angiographic Success is defined as stent delivery with 30% residual stenosis and without serious angiographic complications. 3. Procedural Success defined as stent delivery with a residual stenosis â?¤30% (core laboratory assessed) and without in-hospital MACE. 4. Angiographic Success defined as stent delivery with â?¤30% residual stenosis and without serious angiographic complications. 5. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. 6. In Hospital MACE & 30 Days of Discharge. 7. Core laboratory assessed data of 100 patient. OCT Sub Study-An Optical Coherence Tomography (OCT) sub-study will be conducted in first 100 participants undergoing OCT at Operators discretion. Timepoint: Time frame for follow-up â?? 30 days and one year for OCT patients. | — |
Countries
India
Contacts
Public ContactDr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited
Outcome results
None listed