NCT07162792尚未招募不适用
The Safety and Efficacy of New-Generation Bioabsorbable Scaffolds Versus Drug-Coated Balloons in the Treatment of De Novo Lesions in Large Coronary Arteries: A Prospective Randomized Controlled Study
Xuzhou Third People's Hospital0 个研究点目标入组 150 人开始时间: 2025年10月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- percentage diameter stenosis
研究概览
简要总结
This study plans to enroll 150 patients who are candidates for "intervention without implantation" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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);
- •either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels;
- •successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria
- •subjects at the age between ≥18 and ≤80 years old;
- •patients with symptoms or evidence of myocardial ischaemia;
- •subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation.
排除标准
- •1. in-stent lesions;
- •For the left main disease, chronic total occlusive lesions;
- •bifurcation lesion (reference vessel diameter of side branch vessels > 2.0 mm);
- •Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation;
- •Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria
- •Any patient with myocardial infarction within one month;
- •Patients with severe congestive heart failure (NYHA Level III severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 40%;
- •Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
- •Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
- •Patients with severe renal failure(eGFR<30ml/minute) or such medical history, failure to comply with angiography conditions;
- •Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer;
- •Patients who plans to accept selective operation within 1 year;
- •Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
- •Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.
研究组 & 干预措施
DCB group
Experimental
干预措施: drug-coated balloon (Device)
BRS group
Experimental
干预措施: bioresorbable scaffold (Device)
结局指标
主要结局
percentage diameter stenosis
时间窗: 12 months
次要结局
未报告次要终点
研究者
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