Health Condition 1: I259- Chronic ischemic heart disease, unspecified
Conditions
Interventions
Intervention1: Balloon Dilatation Catheter: The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery of bypass graft stenosis for the purpose of
Sponsors
Newtech Medical Devices Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older male and female Diagnosis of coronary artery disease requiring elective percutaneous transluminal coronary angioplasty PTCA in a native coronary artery or coronary artery bypass graft. Presence of a significant stenotic lesion of 70 percent or more in one or more coronary vessels suitable for balloon angioplasty using the investigational device. Target lesion is angiographically accessible and crossable with a balloon catheter. Reference vessel diameter and lesion characteristics are within the available balloon size range eg 2.25 mm to 4.0 mm specified in the device IFU. Subject is eligible to undergo angiography and interventional procedures under local anesthesia. Subject or legally authorized representative has provided written informed consent prior to enrollment. Willing and able to comply with the protocol-required follow-up schedule.
Exclusion criteria
Exclusion criteria: Unprotected left main coronary artery disease as noted in the IFU under contraindications. Presence of coronary artery spasm in the absence of significant stenosis, per IFU contraindications. Acute ST-elevation myocardial infarction STEMI requiring emergency intervention. Presence of chronic total occlusion or heavily calcified lesions not suitable for balloon angioplasty alone. Known bleeding disorders or abnormal blood clotting profiles, such as an INR greater than 1.5 or a platelet count less than 100,000 per cubic millimeter. Severe left ventricular dysfunction with an ejection fraction less than 30 percent or hemodynamic instability. History of hypersensitivity or contraindication to contrast media, heparin, or balloon materials. Participation in another investigational device or drug study within the last 30 days. Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception. Life expectancy of less than 90 days due to non-cardiac health conditions, such as advanced cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and performance of the Newtech Balloon Dilatation Catheter in achieving successful dilatation of stenotic lesions in coronary arteries or bypass grafts in patients with myocardial ischemia. To assess the procedural success rate, defined as successful delivery, inflation, and withdrawal of the catheter without device-related complications. Timepoint: Pre-operative, Operative Day, Day2, Day7 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of device-related adverse events during immediately after the procedure eg vessel dissection perforation acute occlusion or spasm To assess angiographic improvement post-procedure such as restoration of target vessel patency improved coronary blood flow. To evaluate the ease of device use including aspects such as catheter deliverability balloon inflation deflation performance overall procedural compatibility. To monitor post-procedural clinical outcomes including any cardiovascular symptoms adverse events, or need for additional interventions during the follow-up period. Timepoint: Pre-operative, Operative Day, Day2, Day7 | — |
Countries
India
Contacts
Public ContactMr Praveen Shukla
Newtech Medical Devices PVT LTD
Outcome results
None listed