SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 13
- 主要终点
- The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)
研究概览
简要总结
BACKGROUD:
Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers.
OCT allows for precise determination of stent placement, stent expansion and apposition. The pattern of vessel healing can be very precisely studied if immediate post-stent implantation OCT/IVUS data is compared to the 6-month post-PCI interval.
While OCT cannot be optimally used for ostial lesion imaging, IVUS can be used to image ostial lesions/stent placement.
Optimal and consistent vessel healing is particularly important in LM PCI where stent thrombosis is a potential complication with serious adverse outcome.
HYPOTHESIS:
Due to the absorption of the polymer of the Boston Scientific Synergy Stent over time, early strut coverage patterns and timeline may be different than previously observed in DES and BMS stents in LM PCI. Late acquired stent malapposition (LASM) is expected to differ from previous observations with traditional DES/BMS.
Stent coverage in LM PCI will be studied with OCT or IVUS at six and 12 months and compared to OCT or IVUS at the time of stent implantation.
OCT/IVUS data will be analyzed in a core lab (CRF) and correlated with clinical outcomes at 6 and 12 months.
详细描述
The proposed study is a multicenter, observational, prospective, single-arm study of stent strut coverage of patients undergoing LM PCI.
Baseline quantitative coronary analysis (QCA) will be performed at the time of stent implantation.
Stent coverage in LM PCI will be studied with OCT at 3 and 12 months and compared to baseline OCT at the time of stent implantation.(31, 32)
OCT/data will be analyzed in a core lab (CTC CRF) and correlated with clinical outcomes at 3 and 12 months.
Primary Endpoint
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age 18 years or greater;
- •Left Main CAD, defined as ≥ 50% diameter stenosis and amenable to re-vascularization by PCI;
- •Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- •Ability to comply with minimum of 6 months of DAPT after the index procedure.
- •Unprotected Left Main PCI
- •Protected Left Main PCI
排除标准
- •Coexisting conditions that limit life expectancy to less than 12 months or that could affect patient's compliance with the protocol;
- •Serum creatinine greater than 2.0 mg/dL;
- •Cardiogenic shock;
- •Non-STEMI, if the cardiac troponin is not stable or starting to decline;
- •Pregnancy;
- •Inability to take dual antiplatelet therapy for 6 months;
- •Any target lesion with previously placed stent.
- •Patients disqualified for CABG surgery.
- •Contraindications for OCT use:
- •Bacteremia or sepsis
- •Major coagulation system abnormalities
- •Severe hemodynamic instability or shock
- •Patients diagnosed with coronary artery spasm
- •Acute renal failure
研究组 & 干预措施
Optical Coherence Tomography
Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible.
干预措施: Optical Coherence Tomography (Device)
结局指标
主要结局
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)
时间窗: 3 Months
The stents from 6 participants were analyzed for strut coverage, which is specifically defined as Percentage of Uncovered Stent Struts. The Percentage of Uncovered Stent Struts is the number of struts without distinct overlying tissue, in which the luminal reflection of the strut surface is directly interfacing with the lumen, divided by total number of analyzable struts.
次要结局
- The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)(12 month)
- 12-month Persistent Stent Malapposition(12 month)
- Major Adverse Cardiac Event (MACE)(MACE reported at 12 months)
- 3-month Persistent Stent Malapposition(3 month)
研究者
Mladen I. Vidovich
Associate Professor of Medicine, University of Illinois at Chicago and Chief of Cardiology, Jesse Brown VA Medical Center
Jesse Brown VA Medical Center