Percutaneous coronary intervention (PCI) is one of the standard treatments for patients with acute and chronic coronary syndromes that are consistently recommended by current national and international guidelines. Currently, even with the most advanced design concepts of drug-eluting stents (DES), the permanent foreign body and in-stent restenosis after implantation are still very detrimental to the clinical outcomes of patients. These problems have been mitigated to some extent by the advent of the drug-coated balloon (DCB), a special balloon coated with an antiproliferative drug that is uniformly delivered to the vessel wall during endovascular dilatation to inhibit endothelial proliferation.
This study is a prospective randomized study of a novel drug-coated balloon for the treatment of de novo coronary artery large vessel lesions. By comparing the clinical outcomes of the novel BA9 drug-coated balloon (BCB) with those of the paclitaxel-coated balloon (PCB) in the treatment of de novo coronary artery large vessel, we evaluated the safety and efficacy of the BCB for such lesions, and provided evidence for the later use of rapamycin-based drug-coated balloons in PCI.
They are randomly dividing them into BCB treatment group and PCB treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation.
Radiography inclusion criteria
angiographically confirmed de novo coronary artery lesion;
target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment);
Radiography exclusion criteria
in-stent lesions;
For the left main disease, true bifurcation lesion, chronic total occlusive lesions;
Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation;