Health Condition 1: I259- Chronic ischemic heart disease, unspecified
Conditions
Interventions
Intervention1: Everolimus-Eluting Coronary Stent Delivery System: The Everolimus eluting stent system is a combination product comprised of two regulated components: a device (a coronary stent system
Sponsors
Newtech Medical Devices Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 years or older male or female. 2.Diagnosis of coronary artery disease CAD with de novo stenotic lesions in native coronary arteries requiring percutaneous coronary intervention PCI. 3.Target lesion is accessible and can be crossed with a guidewire and balloon catheter. 4.Subject is clinically stable and eligible to undergo angiography and PCI under local anaesthesia. 5.Subject or legally authorized representative has provided written informed consent prior to participation. 6.Subject is willing and able to comply with all protocol-required follow-up visits and assessments
Exclusion criteria
Exclusion criteria: 1.Patients who are not candidates for coronary bypass surgery. 2.Patients with a target lesion involving a major side branch. 3.Patients with angiographic evidence of existing thrombus at the intended lesion site. 4.Patients with known hypersensitivity or allergy to cobalt-chromium L605 alloy. 5.Patients with a contraindication to antiplatelet or anticoagulant therapy including Recent major surgery Obstetric delivery Organ biopsy Active gastrointestinal bleeding History of cerebrovascular accident CVA Diabetic retinopathy any other condition associated with increased bleeding risk. 6.Pregnant women or women of childbearing potential. 7.Patients who have experienced a recent acute myocardial infarction within the past 7 days 8.Patients with diffuse coronary artery disease, defined as long segments of abnormal vessel without normal interposed segment. 9.Transplant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the safety and performance of the Newtech Everolimus-Eluting Coronary Stent in treating new coronary artery blockages during PCI, without major device-related complications during the procedure and follow-up. 2.To assess procedural success, defined as successful stent delivery, deployment, and removal without device-related complications. Timepoint: Procedure Day, Procedure(Day2), Day30, Day90, Day180 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor early device-related adverse events following implantation, including acute or subacute thrombosis, unstable angina, ventricular fibrillation, or access site complications such as hematoma, bleeding, or pseudoaneurysm. To assess angiographic performance using quantitative coronary angiography (QCA) both during the procedure and throughout follow-up visits. To assess the handling characteristics of the device during the procedure, including fluoroscopic visibility, ease of tracking and lesion crossing, inflation and deflation performance of the balloon, and overall compatibility with the guidewire and catheter system. To ensure clinical adherence to the Instructions for Use by confirming appropriate patient selection, proper use of the stent within the indicated vessel diameter and lesion length, avoiding reuse of the device, and confirming compliance with storage and expiry conditions.Timepoint: Procedure Day, Procedure(Day2), Day30, Day90, Day180 | — |
Countries
India
Contacts
Public ContactMr Praveen Shukla
Newtech Medical Devices PVT LTD
Outcome results
None listed