Health Condition 1: I213- ST elevation (STEMI) myocardial infarction of unspecified site
Conditions
Interventions
Intervention1: Single Universal Catheter - Ikari Left: In the intervention group, patients will undergo both angiography and percutaneous coronary intervention (PCI) using a single, universal Ikari Le
Sponsors
Terumo Corporation
Eligibility
Inclusion criteria
Inclusion criteria: a) Patients above 18 years of age who arrived at the emergency room within 24 hours of STEMI onset b) Patients who are able to provide written, informed consent to the PCI procedure
Exclusion criteria
Exclusion criteria: Patients with the following characteristics will be excluded: a) Non-palpable radial pulse; b) Temporary pacemaker placement before PCI; c) Arteriovenous fistula in the right thoracic limb; d) Presence of ascending thoracic aortic aneurysm; e) Patients who underwent an interventional procedure other than PCI; f) Patients with bifurcation lesions, which may require more specialized catheter approaches not suitable for a two-catheter or universal catheter strategy or 7-F systems; g) Coronary artery anomalies that may require specific access techniques beyond the scope of the study; h) Severe coronary tortuosity or stenosis at the takeoff of the coronary arteries that makes successful catheter engagement impossible or unsafe. g) Patients in whom the lesions are not amenable for PCI and require surgical options such as coronary artery bypass graft (CABG); h) Patients with failed radial access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the difference of the fluoroscopy to device (FluTD) time between the single, universal Ikari Left guiding catheter strategy versus the conventional two catheter strategy. FluTD is defined as the time from the initial guide catheter or diagnostic catheter visualisation in ascending aorta to the time of device entry into the culprit coronary artery. Measured at the time of PCI procedure immediately after randomizationTimepoint: The primary outcome is a time metric measured when patients undergo the index angiography and PCI procedure, following onset and diagnosis of STEMI. As such, the primary outcome measure does not have follow-up timepoints and will be measured at a single instance during the procedure. The FluTD time measured during the procedure will be documented in fluoroscopy logs for subsequent analysis. Primary outcome will be assessed at baseline (day 0) only, since it is a procedure timing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Major Adverse Cardiovascular Events (MACE) including death, myocardial infarction, stroke, or revascularization of target vessel.Timepoint: 30 days post-PCI;Procedural success rate, which is defined as the successful completion of index PCI procedure without any significant complications including conversion to surgery, failure to achieve revascularization or target vessel patency, bleeding events, and/or any device related complications.Timepoint: Peri-procedure and post-procedure (until the duration of patient stay in the hospital);Assessing the impact of reduced FluTD time on left ventricular (LV) function, as measured by GLS using echocardiogram.Timepoint: 24 hours post-pCI, 3 months post-PCI;Evaluating impact of reduced FluTD time on overall myocardial function by quantifying scar burden, ischemic burden, and degree of coronary microvascular obstruction using cardiac magnetic resonance imaging.Timepoint: 3-months post-PCI | — |
Countries
India
Contacts
Public ContactDr Meena Iyer
Sri Ramachandra Institute of Higher Education and Research
Outcome results
None listed