Trial Goals:
1. Evaluation of Mid- to Long-Term Safety and Effectiveness of Drug-Coated Autoperfusion Balloon Dilatation Catheter (DCAB) versus Conventional Drug coated balloon (DCB) in Patients with ST Segment Elevation Myocardial Infarction (STEMI). 2. Evaluation of Hybrid IVUS-OCT System for Intraoperative Evaluation of DCAB or Conventional DCB Treatment Safety and Effectiveness for De Novo Lesions During Emergency Percutaneous Coronary Intervention (PCI) in Patients with STEMI.
The primary outcome is late lumen loss (LLL) assessed at 9 months following emergency PCI, measured using quantitative coronary angiography (QCA).
Acute ST-Elevation Myocardial Infarction Meeting PPCI Criteria: 1) Chest pain lasting more than 20 minutes, with ST-segment elevation of at least 1 mm in two or more adjacent leads, new left bundle branch block, or evidence of posterior wall myocardial infarction; 2) Onset of symptoms within 12 hours.
Patients Who Have Received Thrombolytic Therapy Within 6 Hours of Symptom Onset and Are Eligible for Rescue PCI Within 24 Hours;
Infarct-Related Artery Selection Imaging and Pre-Treatment Criteria Meeting PPCI Standards: 1) De novo lesions. 2) Reference vessel diameter between 2.5 mm and 4 mm. 3) Successful pre-treatment of target lesions: post-pre-treatment residual stenosis of the culprit vessel ≤ 30%, with no type C dissections (or intravascular imaging indicating significant residual plaque burden at the site of dissection, with transverse expansion > 60°, longitudinal expansion > 2 mm, dissection involving the media or adventitia, and located at the distal end of the stent), no hematoma, and no significant thrombus (TIMI thrombus burden grade ≤ 2);
Sufficient compliance with the study protocol, agreement to undertake follow-up, and coronary angiography at 9 months;
Age < 18 years and > 75 years;
History of prior myocardial infarction;
Allergy to contrast agent/inability to tolerate contrast;
Known contraindications / inability to tolerate bivalirudin, fondaparinux, heparin, aspirin, clopidogrel, and/or ticagrelor;
Parallel
Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）
DeviceIn the experimental arm, under the assessment and guidance of IVUS-OCT, STEMI patients with successfully prepared lesions will be treated with a drug-coated autoperfusion balloon dilatation catheter (DCAB). Successful lesion preparation is defined as post-pretreatment residual stenosis ≤ 30%, no type C dissections, intravascular imaging confirming no significant residual plaque burden at the dissection site, no transverse expansion \> 60°, no longitudinal expansion \> 2 mm, no dissection involving the media or adventitia, and no location at the stent distal end. There should be no hematoma and no significant thrombus (TIMI thrombus burden grade ≤ 2). If the angiographic and intravascular imaging results after DCAB treatment are unsatisfactory, an emergency drug-eluting stent (DES) will be implanted.
Conventional Drug coated balloon (DCB)
DeviceIn the control arm, under the assessment and guidance of IVUS-OCT, STEMI patients with successful lesion preparation (residual stenosis ≤ 30%, no type C dissections, no significant residual plaque burden, no dissection involving the media or adventitia, no transverse expansion \> 60°, no longitudinal expansion \> 2 mm, no location at the stent distal end, no hematoma, TIMI thrombus burden grade ≤ 2) will be treated with a conventional DCB coated with 3 μg/mm2 paclitaxel. If angiographic and intravascular imaging results are unsatisfactory, a bailout DES will be implanted.
Late lumen loss at 9 months after index PCI
Late lumen loss, as assessed by quantitative coronary angiography, at 9 months following the index percutaneous coronary intervention.
Incidence of patient-oriented composite endpoint (PoCE)
Incidence of patient-oriented composite endpoint (PoCE) and individual components of PoCE: defined as a composite of all-cause death, Target vessel failure, any stroke, any myocardial infarction (MI), and any clinically or physiologically indicated revascularization.
Incidence of Bleeding Academic Research Consortium bleeding type 3 and 5 bleeding complications
Bleeding Academic Research Consortium type 3 and 5 bleeding complications
Incidence of coronary dissection, categorized by Types A, B, C, and D-F, immediately following DCB implantation
Based on the results of coronary angiography after DCB implantation
The incidence of bailout stenting following DCB implantation
The following criteria are used to define it: TIMI flow ≤ Grade 2; residual stenosis \> 30%; Type C (or intravascular imaging demonstrating significant residual plaque burden at the dissection site, lateral extension \> 60°, longitudinal extension \> 2 mm, dissection involving the media or adventitia); and higher dissection.
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