Coronary Arterial Disease (CAD)
Conditions
Keywords
paclitaxel-coated balloon, biolimus-coated balloon, de novo lesions, large coronary artery vessel
Brief summary
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.
Interventions
DEVICEbiolimus-coated balloon
238 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Biolimus-coated balloon.
237 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of paclitaxel-coated balloon.
Sponsors
Xuzhou Third People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Radiography inclusion criteria 1. angiographically confirmed de novo coronary artery lesion; 2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment); 3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment); 4. either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels; 5. successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria <!-- --> 1. subjects at the age between ≥18 and ≤80 years old; 2. patients with symptoms or evidence of myocardial ischaemia; 3. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation and at 30 days, 6 months, 9 months and 12 months after operation.
Exclusion criteria
* Radiography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major adverse cardiovascular events | 12 months | include cardiac death, non-fatal myocardial infarction, and target lesion revascularization. |
Contacts
Primary Contactyaojun zhang, Ph.D.
Outcome results
None listed