Evaluation of Neointimal Coverage and Vessel Wall Response After Implantation of Ultrathin Strut Biodegradable Polymer-coated Sirolimus-eluting Stent in STEMI Patients by Optical Coherence Tomography
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
- 2. Thickness of neointimal hyperplasia (NIH) over covered struts
研究概览
简要总结
This is a prospective, single center,single-arm, investigator-initiated study to evaluate neointimal coverage andvessel wall response after implantation of SupralimusGrace sirolimus-eluting stent in ST-elevation Myocardial Infarction patients by optical coherence tomography (OCT) analysis. All patients will beevaluated by OCT analysis at 3 months after the indexprocedure.
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
- •Acute Myocardial Infarction (MI) with ST-segment elevation, within 12 hours from symptoms onset
- •Native coronary artery disease with >70% diameter stenosis (no prior stent implant, no prior brachytherapy)
- •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
- •Lesions in coronary artery bypass grafts
- •Significant left main disease
- •Killip class IV
- •Recent major bleeding (6 months)
- •Renal failure with creatinine value >2.5 mg/dl
- •Contraindication to antiplatelet therapy or a history of hypersensitivity to sirolimus or structurally related compounds
- •Patient in anticoagulant therapy
- •Internal mammary artery (IMA) due to a stent thrombosis
- •No suitable anatomy for OCT scan in the opinion of investigator.
结局指标
主要结局
2. Thickness of neointimal hyperplasia (NIH) over covered struts
时间窗: 3 Months
3. Proportion of malapposed struts
时间窗: 3 Months
1. Proportion of covered struts
时间窗: 3 Months
4. Mean malapposed strut-to-lumen distance
时间窗: 3 Months
Strut-level analysis:
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
3. Incomplete stent apposition (ISA) area and volume
时间窗: 3 Months
Cross-section level analysis
时间窗: 3 Months
1. NIH area, volume
时间窗: 3 Months
次要结局
- Qualitative NIH assessment at follow-up:(- Proportion of cross-sections with peri-strut low intensity areas (PLIA) and neoatherosclerosis)
- Serial changes in mean lumen area, minimum lumen area, and ISA area from post-procedure to the assigned follow-up period(3 Months)