NCT07399002招募中不适用
Long Coronary Lesions: Safety and Performance of the Ultimaster Nagomi™ Stent in This Setting With a One-to-one Approach -One Lesion, One Stent- LONG NAGOMI™ PMCF STUDY
Fundación EPIC10 个研究点 分布在 1 个国家目标入组 1,039 人开始时间: 2026年2月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,039
- 试验地点
- 10
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
The study is designed as a prospective, multi-center, observational PMCF (post-market clinical follow-up) study of the Ultimaster Nagomi™ _stent (lengths of 38, 44 and 50 mm) in the treatment of coronary artery disease according to the indications approved in the CE marking.
详细描述
The study serves to fulfill post marketing surveillance requirements for the Ultimaster Nagomi™ stent. This is a PMCF study of real-world use of the Ultimaster Nagomi™ DES aimed to reaffirm the device claims of effectiveness and safety, no comparator is required to meet these specified objectives and endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients who meet ALL inclusion criteria will be included:
- •Patients aged ≥ 18 years AND;
- •Patients who according to standard practice of the hospital are amenable to PCI as indicated and considered adequate according to the European clinical practice guidelines on coronary revascularization AND;
- •Patients with at least one lesion fulfilling the "long lesion criteria" suitable for a single stent approach AND;
- •Patients who have been informed of the characteristics of the study and have provided written informed consent AND;
- •Intention to treat all lesions with the Ultimaster Nagomi™ stent
排除标准
- •Patients must not meet any of the following exclusion criteria:
- •Patients who expressly decline to participate in the study.
- •Pregnant or breastfeeding women.
- •Patients with acute coronary syndrome (ACS) under conditions of cardiogenic shock (Killip class 4).
- •Patients with contraindications or hypersensitivity to sirolimus.
- •Patients with a life expectancy of less than 2 years.
- •Patients in whom any surgery requiring general anesthesia is planned, comorbidity or indication likely necessitating the discontinuation of dual anti-platelet therapy before the recommended duration of dual anti-platelet therapy per the ESC or national guidelines.
- •Patients included in other clinical trials that did not reach the primary objective.
研究组 & 干预措施
Coronary Artery Disease (CAD)
干预措施: LONG NAGOMI (Device)
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 1 year
Target Lesion Failure defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization at 1-year post-procedure.
次要结局
- Device success(Periprocedural)
- Safety of the stent: Freedom from Accidental dislodgement of the stent(Periprocedural)
- Safety of the stent: Freedom from Balloon rupture(Periprocedural)
- Safety of the stent: Freedom from Hypotube rupture o Hypotube rupture(Periprocedural)
- Safety of the procedure: Freedom from Challenging withdrawal(Periprocedural)
- Safety of the procedure: Freedom from coronary perforation(Periprocedural)
- Safety of the procedure: Freedom from dissection >C(Periprocedural)
- Safety of the procedure: Freedom from no-reflow(Periprocedural)
- Safety of the procedure: Freedom from stent thrombosis(Periprocedural)
- Procedure success(Periprocedural)
- Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions(Periprocedural)
- Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels(Periprocedural)
- Performance of the Ultimaster Nagomi™ stent in Distal vessels(Periprocedural)
- Angina status assessment Seattle Angina Questionnaire (SAQ)(Baseline)
- Angina status assessment Seattle Angina Questionnaire (SAQ)(12 monts)
- Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire(After PCI)
- Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire(12 Months)
- Cardiovascular death(12 months)
- Target-vessel related myocardial infarction(12 Months)
- Clinically driven target lesion revascularization(12 months)
研究者
研究点 (10)
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