Health Condition 1: I708- Atherosclerosis of other arteries
Conditions
Interventions
Intervention1: Vector NC PTCA balloon catheter: Vector NC PTCA balloon catheter is Rapid Exchange Percutaneous Transluminal Coronary Angioplasty Dilation Catheter designed to allow easy exchange of c
Sponsors
Dr Ajay Mahajan
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient Male and Female both inclusive must be at least 18 years of age at the time of signing the informed consent. 2. All patients having acute MI or chronic coronary syndrome irrespective of duration with coronary angiography showing at least one lesion more than 70 percent luminal stenosis. No adhoc angioplasty patients will be enrolled. 3. Lesion must be successfully crossed with a guide wire without complications, with a maximum of five attempts. 4. Subject or legally authorized representative must provide written informed consent prior to any study related procedure. 5. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure to obtain informed Consent 6. Subjects 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.
Exclusion criteria
Exclusion criteria: 1. Subject with a known hypersensitivity, severe reactions or contraindicated to Aspirin, Heparin, Bivalirudin, antiplatelet medications, or sensitivity to contrast media which cannot be adequately premedicated. 2. Pregnant women. 3. Subject has a known left ventricular ejection fraction LVEF less than 30 percent LVEF may be obtained at the time of index procedure if the value is unknown, if necessary. 4. Patients with severe systemic diseases like renal failure eGFR less than 30 mL/min/m2, uncontrolled diabetes, active infection, respiratory failure or cardiac failure. 5. Patients having no lesion more than 70 percent luminal stenosis will be excluded from study. 6. Patients no consistent with IFU.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Successful delivery, inflation, deflation & withdrawal of balloon. 2. No perforation, flow limiting dissection or reduction into TIMI Flow grade.Timepoint: Immediately after interventional procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Ajay Mahajan
Seth GS Medical College and KEM Hospital
Outcome results
None listed