Safety and Efficacy of POT PTCA Balloon Dilatation Catheter for the Optimal Dilation After Drug-eluting Stent Implantation: a Prospective, Multicenter, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Minimal stent area
研究概览
简要总结
The objective of this randomized control trial is to gain clinical insight on the use of POT PTCA balloon dilatation catheter for the optimal dilation after drug-eluting stent implantation.
详细描述
The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in minimal stent area (MLA) of POT PTCA balloon dilatation catheter on patients with drug-eluting stent (DES) implantation. Based on the previous studies, the MLA in the proximal and distal 3mm segments was 7.38 mm^2 and 8.08 mm^2 before non-compliant balloon (NCB) dilation, respectively. After NCB dilation, that MSA in the proximal and distal 3mm segments was 7.53mm^2 and 9.55mm^2, respectively. As a result, a total of 48 patients with DES implantation are randomized at a ratio of 1:1 to either POT PTCA balloon dilatation catheter group (POT group) or Quantum Maverick balloon catheter group (NCB group) using a randomization schedule blocked by site.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures;
- •Men and women 18 years and older;
- •Patients with asymptomatic myocardial ischemia, stable or unstable angina, or acute myocardial infarction with symptoms lasting more than 12 hours;
- •The target lesions was de novo lesion;
- •Reference vessel diameter of target lesion is between 2.25-4.0mm, and the lesion length is less than 15mm(visual inspection);
- •Diameter stenosis of target lesion diameter ≥70% or ≥50%(visual) with ischemia evidence;
- •DES was successfully implanted in target lesions;
- •TIMI 3 blood flow of target vessel before post-dilation.
排除标准
- •Subjects had clinical symptoms and/or ECG changes consistent with ST-elevation myocardial infarction within 12 hours;
- •Allergies to concomitant medications required by the balloon/stent system or protocol used in the study;
- •Cannot tolerate dual antiplatelet therapy;
- •Life expectancy is less than 6 months;
- •Pregnant or lactating women;
- •Participating in another clinical trial and has not completed the primary endpoint observation of the trial;
- •Planned multiple operations, failed to follow the treatment prescribed in the protocol or affected data analysis and interpretation;
- •Restenosis disease;
- •Target lesions with severe calcification require rotary grinding treatment.
结局指标
主要结局
Minimal stent area
时间窗: through PCI procedure completion
The change of minimum stent area measured by intravascular ultrasound.
次要结局
- PCI success(up to 7 days)
- Device success(through PCI procedure completion)
研究者
Shaoliang Chen, MD
Vice President of Nanjing First Hospital, Director of Cardiovascular Department
Nanjing First Hospital, Nanjing Medical University