Vascular Response in Patients with Diabetes Mellitus: An Optical Coherence Tomography Study of Ultrathin Strut Biodegradable Polymer-coated Sirolimus-eluting Stent
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1. Proportion of covered struts
研究概览
简要总结
This is a prospective, single center, single-arm, investigator-initiated study. The objective of this study is to evaluate the completeness of struts coverage and vessel wall response at 3 months after implantation of Supralimus Grace sirolimus-eluting stent in patients with diabetes mellitus by optical coherence tomography (OCT) analysis.
OCT is a new light-based intracoronary imaging modality with unprecedented spatial resolution. Currently, its axial resolution is only 15 μm, that is, 10 times higher than that of more classical techniques such as intravascular ultrasound (IVUS) based on ultrasounds (150 μm). OCT therefore provides extremely high-quality images of the coronary wall, especially of the structures closest to the vessel lumen. OCT is emerging as a new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque, and neointimal proliferation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient must be at least 18 years of age
- •Patient with symptomatic coronary artery disease
- •Stable patients with diabetes mellitus
- •Only Supralimus Grace stent(s) is/are to be implanted into the coronary vasculature during the index procedure
- •Able to understand and sign the written informed consent form
- •Able and willing to follow the protocol requirements.
排除标准
- •ST-segment elevation myocardial infarction within 7 days prior to the index procedure
- •Life expectancy <12 months due to another medical condition
- •Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus or structurally related compounds
- •Creatinine level more than 2.0 mg/dL or ESRD
- •Severe hepatic dysfunction (more than 3 times normal reference values)
- •Planned surgery procedure ≤3 months post-index procedure
- •Known allergy to cobalt-chromium
- •Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 3 months post index procedure
- •No suitable anatomy for OCT scan in the opinion of investigator.
结局指标
主要结局
1. Proportion of covered struts
时间窗: 3 Months
Strut-level analysis:
时间窗: 3 Months
2. Thickness of neointimal hyperplasia (NIH) over covered struts
时间窗: 3 Months
3. Proportion of malapposed struts
时间窗: 3 Months
4. Mean malapposed strut-to-lumen distance
时间窗: 3 Months
1. NIH area, volume
时间窗: 3 Months
5. Ratio of uncovered struts to total struts (RUTTS)
时间窗: 3 Months
6. Maximum length of consecutive segments of uncovered and malapposed struts
时间窗: 3 Months
2. Percent volumetric stent obstruction
时间窗: 3 Months
Cross-section level analysis:
时间窗: 3 Months
3. Incomplete stent apposition (ISA) area and volume
时间窗: 3 Months
次要结局
- Serial changes in mean lumen area, minimum lumen area, and ISA area from post-procedure to the assigned follow-up period(3 Months)
- Qualitative NIH assessment at follow-up:(- Proportion of cross-sections with peri-strut low intensity areas (PLIA) and neoatherosclerosis)