NCT04796038已完成不适用
Evaluation of the Acute Safety and Device Success of the RISE SC Coronary Balloon Dilatation Catheter When Used as a Dilatation Device in the Stenotic Portion of a Coronary Artery or Bypass Graft in Patients With Coronary Artery Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- Percentage of treated lesions with device success defined as:
研究概览
简要总结
Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for data collection. Patients will be enrolled in up to 5 investigational sites in Switzerland.
The patients will be followed up until discharge or until 7 days, whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •General Inclusion Criteria
- •Subject must be at least 18 years of age.
- •Subject or a legally authorised representative must provide written informed consent prior to any study related procedure.
- •Subject must have stenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
- •Subject must agree to undergo all protocol-required follow-up procedures.
- •Subject must agree not to participate in any other clinical study during hospitalisation for the index procedure.
- •Angiographic Inclusion Criteria All angiographic inclusion criteria are based on visual estimation.
- •De novo or restenotic lesions in native coronary arteries or bypass grafts.
- •A maximum of two lesions, with either both in one vessel or one lesion in each of two vessels.
- •The target lesion(s) must have a diameter stenosis of ≥ 50% by visual estimation or online quantitative coronary angiography (QCA) and may include chronic total occlusions (CTO).
排除标准
- •General Exclusion Criteria
- •Planned use of a non-study angioplasty balloon during the procedure for pre-dilatation or dilatation of the lesion.
- •Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, other anti-platelet medications, or sensitivity to contrast media, which cannot be adequately pre-treated.
- •Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm
- •Subject is currently participating in an investigational study that may confound the treatment or outcomes of this study.
- •Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- •Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.
- •Unprotected left main coronary artery disease
- •More than two lesions requiring treatment. Tandem lesions, defined as multiple, focal lesions that can be covered by one balloon, will be considered as a single lesion.
- •Coronary artery spasm in the absence of significant stenosis.
- •Anticipated need for plaque modification using rotational/orbital atherectomy or intravascular lithotripsy. Note: The use of scoring or cutting balloons after (pre)-dilatation with the study device is allowed.
- •Additional clinically significant lesion(s) in any coronary arteries or bypass grafts for which PCI may be required during hospitalization for the index procedure (in-hospital staged PCI).
研究组 & 干预措施
Rise SC
Experimental
All patients will receive the Rise semi-compliant balloon catheter as per treatment.
干预措施: Balloon dilatation (Device)
结局指标
主要结局
Percentage of treated lesions with device success defined as:
时间窗: During the interventional procedure
1. Successful device delivery and 2. Successful inflation and deflation of the balloon and 3. No perforation, flow-limiting dissection or reduction in TIMI flow grade and 4. No life-threatening arrhythmias (sustained Ventricular Tachycardia (VT), Ventricular Fibrillation (VF))
次要结局
- Percentage of patients with Individual components of device success defined as:(During the interventional procedure)
- Percentage of patients with Procedural success defined as:(1 - 7 Days)
- Percentage of patients with Target Lesion Failure (TLF)(1 - 7 Days)
研究者
研究点 (3)
Loading locations...
相似试验
招募中
不适用
Access Cannulation Trial IIComplications DialysisVascular Access ComplicationNCT05490225Voyager Biomedical100
Unknown
2 期
The Safety and Efficacy of the Combination of Raltitrexed for Injection and Nab-Paclitaxel in Advanced Pancreatic CancerChemotherapy EffectPancreatic CancerNCT04581876Fudan University120
已完成
2 期
Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies: Follow-up StudyHepatocellular CarcinomaNCT02745483Seoul National University Hospital153
招募中
1 期
Chimeric Natural Killer Receptor-Universal T Cells for Relapsed or Refractory NeuroblastomaNeuroblastoma, Recurrent, RefractoryNCT06751134Nanjing Children's Hospital12
已完成
不适用
Sunstone IPL (Intense Pulsed Light) for Hair ReductionHair RemovalNCT03921814Philips Healthcare102