A Prospective, Interventional, Single-Center, Single-Arm Clinical Investigation to Assess the Safety and Performance of the Newtech Sirolimus-Eluting Coronary Stent System in Patients with Symptomatic Ischemic Heart Disease Undergoing Percutaneous Transluminal Coronary Angioplasty (PTCA).
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Newtech Medical Devices Pvt. Ltd.
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To evaluate the safety, performance, and procedural success of the Newtech Sirolimus-Eluting Coronary Stent System in achieving successful revascularization of de novo coronary artery lesions in CAD patients undergoing PCI without major device-related complications.
Overview
Brief Summary
This is a prospective, interventional, Single-center, single-arm, open-label clinical investigation designed to evaluate the clinical safety and performance of the Newtech Sirolimus-Eluting Coronary Stent System in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). The study will include approximately 90 patients presenting with de novo atherosclerotic lesions in native coronary arteries who are eligible for stent placement in accordance with standard interventional cardiology practice. Subjects will be enrolled after providing written informed consent and undergoing screening as per the predefined inclusion and exclusion criteria.
Study Design
- Study Type
- Interventional
- Allocation
- Na
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
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
- •1.Patients who are not candidates for coronary bypass surgery.
- •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 9Transplant patients.
Outcomes
Primary Outcomes
To evaluate the safety, performance, and procedural success of the Newtech Sirolimus-Eluting Coronary Stent System in achieving successful revascularization of de novo coronary artery lesions in CAD patients undergoing PCI without major device-related complications.
Time Frame: Procedure Day, Post-Procedure,Day30, Day90, Day180
Secondary Outcomes
- To monitor early device-related adverse events assess angiographic performance using QCA during the procedure follow-up evaluate handling characteristics, including visibility tracking balloon performance system compatibility ensure adherence to the Instructions for Use regarding patient selection device application storage conditions
Investigators
Dr Vikas Gupta
Heart and General Hospital Jaipur