Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Kamal Encon Industries Limited
Clicebo Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject 18 years of age or older 2. Subjects of all genders 3. Patients with coronary artery disease with one or more de-novo or ISR lesions and candidate for PCI 4. Patients who underwent PCI with at least one Polaris SCB 5. Patients willing to sign an informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women. 2. Patients undergoing planned surgery within 3 months with the necessity to stop DAPT. 3. Patients having left main coronary artery disease. 4. Patients with LVEF less or equal to 25 percent. 5. Patients experiencing STEMI or cardiogenic shock related to an acute MI within 2 days prior to index procedure. 6. Patient whose medical conditions, whether cardiovascular or other, may restrict patient s participation in a study. 7. Patients with life expectancy less than 12 months. 8. Patient with history of stroke within 6 months of Index procedure. 9. Patients with known hypersensitivity or allergy to any components required for PCI procedures such as the angioplasty device materials like polymers, drugs, and contrast media. 10. Known intolerance to antiplatelet or anticoagulant therapy required for PTCA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of MACE a composite endpoint of Cardiovascular death, Non-Fatal Myocardial Infarction, and Target Vessel Revascularization at 360 days post PCITimepoint: 360 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedural outcomes -Device success defined as the ability of the study device to be delivered, dilated and retrieved from the target lesion. -Procedure success defined as angiographic success (residual stenosis less than or equal to 20 percent), absence of major complications (dissections greater than type C, acute vessel closure, perforations, thrombosis, no bailout stenting) and TIMI flow greater than grade II during hospitalizationTimepoint: Hospitalization;Incidence of MACETimepoint: Discharge 30 days 180 days;Incidence of TLF -Cardiovascular death -Target Vessel Myocardial Infarction (TV-MI) -Target Lesion Revascularization (TLR)Timepoint: Discharge 30 days 180 days 360 days;Incidence of major adverse cardiac and cerebrovascular events (MACCE) -MI -TVR -CV death -Stroke Timepoint: Discharge 30 days 180 days 360 days;Incidence of vessel thrombosis (ARC 2 and latency definition)Timepoint: Discharge 30 days 180 days 360 days;Incidence of bleeding (BARC greater than 3)Timepoint: Discharge 30 days 180 days 360 days;QCA endpoints -Late Lumen Loss, -Minimal lumen diameter (MLD) -percentage diameter stenosis (DS) -Angiographic binary restenosis IVUS endpoints -Target vessel morphology -Neointimal volume or change in atheroma volumeTimepoint: Index Procedure and 6 Months | — |
Countries
India
Contacts
Public ContactNagma Khan
Medanta- The Medicity
Outcome results
None listed