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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
In 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.
In 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.
LanZhou University
Lanzhou, Gansu, China
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.
Time frame: 9±2 months
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.
Time frame: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
Incidence of Bleeding Academic Research Consortium bleeding type 3 and 5 bleeding complications
Bleeding Academic Research Consortium type 3 and 5 bleeding complications
Time frame: 3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI
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
Time frame: index PCI
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.
Time frame: index PCI
Minimum lumen area and Lumen Area Loss Immediately After DCB Implantation by IVUS-OCT Intravascular Imaging.
Change in minimum lumen area and lumen area loss (in mm2), as assessed by IVUS-OCT multimodal imaging, compared with pre-procedure baseline following coronary artery drug-coated balloon angioplasty.
Time frame: index PCI
Incidence of intolerable adverse events during the duration of coronary artery drug-coated balloon dilation.
Incidence of intolerable worsening chest pain, hemodynamic instability, ST-segment changes, and severe arrhythmias during DCB expansion and duration of DCB expansion.
Time frame: index PCI
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