Health Condition 1: I200- Unstable angina
Conditions
Interventions
Intervention1: Percutaneous coronary intervention: 3V PAULO (Angioplasty PTCA Balloon Catheter) will be used in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary i
Sponsors
SV Vascular Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: A. Clinical Inclusion Criteria: 1. Subject is >= 18 years of age. 2. Subject or a legally authorized representative (LAR) must provide written informed consent prior to any study related procedures. 3. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study. 4. Subject must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia. B. Angiographic Inclusion Criteria 1. Subject must have de novo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. An embolic protection device must be used in all Saphenous venous grafts (SVG) interventions performed during the index procedure. 2. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries. 3. Target and non-target lesions must be located in different coronary arteries or bypass grafts. 4. Target lesion(s) must have a diameter stenosis of >=70% by visual estimation and may include chronic total occlusions (CTO) 5. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success.
Exclusion criteria
Exclusion criteria: A. Clinical Exclusion Criteria: 1. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated. 2. Subject with known diagnosis of an acute myocardial infarction (AMI) within 72 hours prior to index procedure. 3. Subject with known pregnancy or is nursing. Women of child- bearing potential should have a documented negative pregnancy test within 7 days before index procedure. 4. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure. 5. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure. 6. Cerebro Vascular Accident (CVA) within the past 6 months. 7. Active peptic ulcer or active Gastro-Intestinal (GI) bleeding within the past 6 months. 8. Subject has a known Left Ventricular Ejection Fraction (LVEF) B. Angiographic Exclusion Criteria 1. More than two lesions requiring treatment. 2. Unprotected left main coronary artery disease. (Greater than 50% diameter stenosis) 3. Coronary artery spasm of the target vessel in the absence of a significant stenosis. 4. Target lesion with angiographic presence of probable or definite thrombus. 5. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter. 6. Non-target lesion to be treated during the index procedure meets any of the following criteria: 7. Located within a bypass graft (venous or arterial) 8. Left main location 9. Chronic total occlusion 10. Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent) 11. Treatment not deemed a clinical angiographic success
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures: Device procedural success consisting of the following: 1. Successful delivery, inflation, deflation and withdrawal of the study balloon 2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon 3. Final TIMI flow grade of 3 at the conclusion of the PCI procedure Timepoint: Through Hospital Discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| The following clinical endpoints will be measured through hospital discharge: 1. In-hospital Major Adverse Cardiac Events (MACE) 1.1. All death (cardiac and non-cardiac) 1.2. Myocardial infarction (MI) 1.3. Target Lesion Revascularization (TLR) 2. In-hospital stent thrombosis (ST) within the target vessel 3. Clinically Significant Arrhythmias (requiring intervention) Timepoint: Through Hospital Discharge | — |
Countries
India
Contacts
Public ContactPrashanth Srirangam
Krishna Institute of Medical Sciences
Outcome results
None listed