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Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes (POLARIS)

2026年6月5日 更新者：Dorian Garin

POLARIS : POLymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 瑞士
      • Geneva、瑞士、1211
        • Geneva University Hospitals (HUG) - Service of Cardiology
        • 接触：
        • 接触：
        • 首席研究员：
          • Juan F Iglesias, MD, FESC, FACC
        • 副研究员：
          • Dorian Garin, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Consecutive adult patients who underwent percutaneous coronary intervention with implantation of at least one ABLUMINUS NP sirolimus-eluting stent at Geneva University Hospitals between January 2021 and December 2025.

描述

Inclusion Criteria:

  • Age >= 18 years at the time of the index procedure.
  • Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025.
  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
POLARIS cohort
Consecutive adult patients who received at least one polymer-free sirolimus-eluting stent during PCI at Geneva University Hospitals between January 2021 and December 2025. No study-mandated procedures; clinical care follows standard institutional practice.
设备：Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)
Thin-strut (73 micrometres) cobalt-chromium coronary stent with polymer-free submicron phospholipid carriers (200-300 nm) delivering sirolimus exclusively to the abluminal surface, and fusion coating extending sirolimus deposition up to 5 mm beyond the stent edges. CE-marked 24 January 2020. Available diameters 2.25-4.0 mm and lengths 8-40 mm. Manufactured by Concept Medical, Tampa, FL, USA. Implantation and peri-procedural care follow operator discretion and institutional standard of care.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Target Lesion Failure (TLF)
大体时间：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.
12 months

次要结果测量

结果测量
措施说明
大体时间
Target Lesion Failure (TLF) at 2 and 5 years
大体时间：2 years; 5 years
Same ARC-2 composite definition as primary endpoint, assessed at 2 and 5 years.
2 years; 5 years
Cardiac death
大体时间：30 days; 12 months; 2 years; 5 years
30 days; 12 months; 2 years; 5 years
Target vessel myocardial infarction
大体时间：30 days; 12 months; 2 years; 5 years
Myocardial infarction attributable to the target vessel, defined per ARC-2 and the 4th Universal Definition of Myocardial Infarction.
30 days; 12 months; 2 years; 5 years
Clinically indicated target lesion revascularisation
大体时间：30 days; 12 months; 2 years; 5 years
30 days; 12 months; 2 years; 5 years
Patient-oriented composite endpoint (POCE)
大体时间：12 months; 2 years; 5 years
Composite of all-cause death, any myocardial infarction, and any revascularisation.
12 months; 2 years; 5 years
Definite or probable stent thrombosis (ARC-2)
大体时间：Acute (0-24h), subacute (1-30d), late (30d-1y), very late (>1y), up to 5 years
Acute (0-24h), subacute (1-30d), late (30d-1y), very late (>1y), up to 5 years
Target vessel failure (TVF)
大体时间：12 months; 2 years; 5 years
Composite of cardiac death, target vessel myocardial infarction, and clinically indicated target vessel revascularisation.
12 months; 2 years; 5 years
Major bleeding (BARC type 3 or 5)
大体时间：12 months; 2 years; 5 years
12 months; 2 years; 5 years
All-cause mortality
大体时间：12 months; 2 years; 5 years
12 months; 2 years; 5 years
Late lumen loss (mm)
大体时间：At clinically indicated follow-up angiography, up to 5 years
In-stent late lumen loss by quantitative coronary angiography, assessed only in patients undergoing clinically indicated follow-up angiography.
At clinically indicated follow-up angiography, up to 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Dorian Garin

调查人员

  • 首席研究员：Juan F Iglesias, MD, FESC, FACC、Geneva University Hospitals (HUG), Interventional Cardiology Unit
  • 研究主任：Dorian Garin, MD、Geneva University Hospitals (HUG), Department of Cardiology

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2036年6月1日

研究注册日期

首次提交

2026年4月24日

首先提交符合 QC 标准的

2026年4月24日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • POLARIS (Alias Study Number)
  • POLARIS v1 04.03.2026 (其他标识符：Sponsor-Investigator protocol version)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Anonymised individual participant data may be made available to other researchers upon reasonable written request addressed to the sponsor-investigator after publication of the primary 12-month results, subject to a data sharing agreement and approval by the competent ethics committee.

IPD 共享时间框架

Starting 6 months after publication of the primary 12-month results, without predefined end date.

IPD 共享访问标准

Reasonable written request to the sponsor-investigator; institutionally approved research protocol; signed data sharing agreement; approval of the competent cantonal ethics committee.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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