Heart disease
Conditions
Interventions
Patients who suffer from coronary artery disease will undergo angiography and
Angioplasty procedure.
Sponsors
Meril Life Sciences Pvt. Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: * The subjects must be >= 18 years of age. * Clinical evidence of ischemic heart disease and / or a positive territorial functional study. - Documented stable angina (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4 ) or - Documented unstable angina with documented ischemia (Braunwald Class IB-C, C-IIB, IIIB or C), or - Documented silent ischemia * The subject having a planned intervention or up to two de novo native lesions * Target lesion reference diameter >= 2.5 mm and
Exclusion criteria
Exclusion criteria: Exclusion criteria: * Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours Preceding the index procedure, Unless the CK and CK-MB enzymes are less than twice the Upper Limit Normal. * The subjects who have a known hypersensitivity or contraindication to any of the requisite medications including aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus, everolimus or the contrast media * There is an untreated significant lesion or> 40% diameter stenosis proximal or distal to the remaining target site after the planned intervention. * Previous PCI with stent placement or any at the target lesion and / or within 10 mm of the target lesion. * Lesion with a significant side branch (branch diameter > 2 mm) thatwould be covered by Stenting * Total occlusion or coronary TIMI 0 flow in the target vessel. * Left main coronary artery disease. * The proximal target vessel or target lesion is severely calcified by visual assessment. aorto-ostial * location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the LAD or LCX. * The subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions * The subject Suffered a stroke, transient ischemic neurological attack (TIA) or significant gastrointestinal (GI) bleeds within the past 6 months * The subject has renal insufficiency as Determined by a creatinine of> 2mg/dl or 180 mg / dl. * The target lesion, or the target vessel proximal to the target lesion contains thrombus * Documented left ventricular ejection fraction of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: The primary endpoint of this study is to assess in-stent Late Lumen Loss at 9 months for both treatment strategies. Late lumen loss is defined as the difference in minimal luminal diameter (MLD) between post-procedural and follow up MLD in mm. The Analysis of primary endpoints is performed on basis of the evaluation of the angiography images by an independent core laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: Angiographic endpoints - In Stent and In segment Binary Restenosis (DS >=50%) at 9 months - In Stent and In segment MLD and %DS post procedure at 9 months - In-segment Late Lumen Loss at 9 months *All measurements will be made of the in-stent, in-segment, proximal and distal stent margins. Clinical endpoints * Acute success (Device and Procedural success) * Major Adverse Cardiac Events (MACE) at 1, 5, 9,12 and 24 months and its individual components. defined as cardiac death, MI and clinically-indicated target Vessel revascularization) * Target Vessel Failure at 1, 5, 9, 12 and 24 months and its individual components. defined as cardiac death, MI not clearly attributable to a non-intervention vessel and clinically-indicated target Vessel revascularization) * Device-oriented Composite Endpoints at 1, 5, 9, 12 and 24 months and its individual components. (Device-oriented Composite Endpoint (DoCE) is defined as cardiac death or MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization) * Non clinically-indicated (Asymptomatic but detected by follow-up angiography) Target Lesion revascularization (TLR) at 1, 5, 9, 12 and 24 months * Clinically-indicated (Due to clinical Features of Ischemia) and non clinically-indicated(Asymptomatic but detected by follow-up angiography) Target Vessel revascularization (TVR) at 1, 5, 9, 12 and 24 months * Stent Thrombosis - according to ARC definitions at all time points | — |
Countries
Netherlands
Outcome results
None listed