Study of Aspiration Catheters for Treatment of Acute ST-Segment Elevation Myocardial Infarction STEMI Using PCI

What this Trial Is About

Researchers are studying the effectiveness and safety of an aspiration catheter device in patients undergoing percutaneous coronary intervention PCI for acute ST-segment elevation myocardial infarction STEMI. This trial aims to compare two types of thrombus aspiration catheters to see how well they perform in restoring blood flow during treatment of STEMI. The study is designed as a prospective, multicenter, randomized controlled trial to evaluate if the new device is not inferior to the control device. Participants will be randomly assigned to receive thrombus aspiration therapy using either the test aspiration catheter or the control Export Advance Aspiration Catheter during their PCI procedure. The intervention involves passing the catheter through the affected coronary artery to remove blood clots. The study includes immediate procedural evaluation and a 30-day follow-up to monitor outcomes and safety. Both groups will undergo similar treatment procedures with different devices. During the study, researchers will assess blood flow restoration immediately after PCI using TIMI flow grade and other related measures such as thrombus grade, ST-segment resolution, and device success rate. Safety will be monitored through adverse event tracking up to 30 days after the procedure. Participants will be involved in follow-up visits to evaluate major adverse cardiac events and overall device performance. The total participation period includes the initial procedure and a 30-day post-procedure observation.

Coronary Aspiration Catheter Clinical Trial