POLARIS : POLymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.
详细描述
BACKGROUND. Newer-generation drug-eluting stents (DES) remain associated with late stent-related adverse events at approximately 2% per year, driven by neoatherosclerosis, delayed endothelial healing, and chronic inflammation attributable to permanent polymer coatings. Polymer-free DES were developed to remove this substrate. The polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) (after: study device) is a novel polymer-free sirolimus-eluting stent built on a thin-strut (73 micrometres) cobalt-chromium platform, with drug delivery via biodegradable phospholipid submicron carriers (200-300 nm) confined to the abluminal surface, and a proprietary fusion coating extending sirolimus up to 5 mm beyond the stent edges. The device received CE marking on 24 January 2020. Only limited non-randomized Indian clinical data exist; no Western clinical data have been published.
OBJECTIVES. Primary: to evaluate device-oriented safety and efficacy (TLF at 12 months) of the stent in an all-comer population undergoing PCI at Geneva University Hospitals. Secondary: TLF at 2 and 5 years; individual components of TLF (cardiac death, target vessel MI, clinically indicated target lesion revascularisation) at 30 days, 12 months, 2 years, and 5 years; patient-oriented composite endpoint (all-cause death, any MI, any revascularisation); stent thrombosis (definite / probable, ARC-2, with temporal classification); target vessel failure; major bleeding (BARC 3 or 5); all-cause mortality; and late lumen loss when angiographic follow-up is available.
DESIGN. Prospective, single-centre, single-arm observational registry (Category A research with human subjects per the Swiss Human Research Act). Hybrid enrolment: retrospective identification from January 2021, prospective consent, and prospective follow-up at 30 days, 12 months, 2 years, and 5 years via medical records and telephone interview.
POPULATION. All consecutive adult patients (>= 18 years) treated with at least one study device stent at Geneva University Hospitals since January 2021, with an indication for PCI according to current European or American guidelines, able to provide written informed consent, and with sufficient knowledge of French, German, English, or Italian.
STATISTICS. Exploratory, descriptive analysis. Binary endpoints with Clopper-Pearson 95% confidence intervals; time-to-event analysis by Kaplan-Meier with Greenwood 95% CIs. Pre-specified exploratory subgroup analyses (sex, clinical presentation, diabetes, age, lesion complexity, stent length) presented as forest plots without between-group p-values. Sensitivity analyses include per-protocol, complete-case, landmark (30 days to 12 months), Fine-Gray competing-risk, and tipping point analyses. Analyses in Python (lifelines, pandas, scipy, statsmodels). Reporting follows STROBE.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 at the time of the index procedure.
- •Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December
- •Implantation of at least one study device
- •Indication for PCI according to current European or American guidelines.
- •Able and willing to provide written informed consent.
- •Sufficient knowledge of French, German, English, or Italian to understand the patient information document.
排除标准
- •Documented refusal to participate in research through opt-out from general consent.
- •Inability to provide informed consent (cognitive impairment or other).
- •Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts).
- •Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent.
- •Participation in another clinical trial that would interfere with the endpoints of this registry.
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months
Device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation, defined per Academic Research Consortium-2 (ARC-2) criteria. Binary categorical variable analysed by time-to-first-event method.
次要结局
- All-cause mortality(12 months; 2 years; 5 years)
- Target Lesion Failure (TLF) at 2 and 5 years(2 years; 5 years)
- Cardiac death(30 days; 12 months; 2 years; 5 years)
- Target vessel myocardial infarction(30 days; 12 months; 2 years; 5 years)
- Clinically indicated target lesion revascularisation(30 days; 12 months; 2 years; 5 years)
- Patient-oriented composite endpoint (POCE)(12 months; 2 years; 5 years)
- Definite or probable stent thrombosis (ARC-2)(Acute (0-24h), subacute (1-30d), late (30d-1y), very late (>1y), up to 5 years)
- Target vessel failure (TVF)(12 months; 2 years; 5 years)
- Major bleeding (BARC type 3 or 5)(12 months; 2 years; 5 years)
- Late lumen loss (mm)(At clinically indicated follow-up angiography, up to 5 years)
研究者
Dorian Garin
Dr Dorian Garin, MD
University Hospital, Geneva