Serial Evaluation of Drug-Eluting Stents Using OCT
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Stent Strut Coverage
研究概览
简要总结
The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three second-generation Drug Eluting Stents (DES) [Xience EES (Abbott Vascular, Santa Clara, CA), Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES (Boston Scientific, Natick, MA)] at 6 weeks post implantation.
Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience EES, Promus EES and will be similar to each other and improved (higher rates of stent strut coverage and lower rates of malapposition) compared to the Resolute ZES at 6 weeks post-implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Clinical need for percutaneous coronary intervention using either a Xience, Promus Element, or Resolute Integrity drug-eluting stent using optical coherence tomography optimization
- •Native coronary artery de novo lesion with ≥70% angiographic percent diameter stenosis by visual estimation
- •Target vessel reference diameter between 2.5 and 4.0 mm by visual estimate
- •Target lesion ≤28 mm in length by visual estimate
- •Agree to participate and provide informed consent
排除标准
- •1.Presentation with acute ST-elevation myocardial infarction (defined as electrocardiographic (ECG) ST-elevation ≥ 2 mm in 2 or more contiguous ECG leads along with symptoms compatible with ischemia)
结局指标
主要结局
Stent Strut Coverage
时间窗: 6 weeks post-implantation
Stent Strut Malapposition
时间窗: 6 weeks post-implantation
次要结局
未报告次要终点
研究者
Shuaib Abdullah, MD
Cardiologist; Assistant Professor, Division of Cardiology, Internal Medicine, UT Southwestern Medical School
North Texas Veterans Healthcare System