NCT05232565已完成不适用
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA Catheters Family
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Arthesys
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy endpoint
研究概览
简要总结
The purpose of this Post market Study is to collect clinical data of the Arthesys PTCA catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
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
- •Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication
- •Patient >18 years
- •Patient who understands the trial requirements and the treatment procedures and provides written informed consent
排除标准
- •Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
结局指标
主要结局
Efficacy endpoint
时间窗: Up to end of PTCA procedure
Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter
Safety endpoint
时间窗: Up to end of PTCA procedure
Successful balloon dilatation without device related adverse event during the dilatation procedure
次要结局
- Performance - pre-dilatation(Up to end of PTCA procedure)
- Performance - post-dilatation(Up to end of PTCA procedure)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters FamilyCoronary Artery StenosisNCT05536180Arthesys60
已完成
不适用
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters FamilyThrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein GraftsNCT05536167Arthesys57
招募中
不适用
Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal ObstructionAcute RhinitisNasal ObstructionRhinosinusitisRhinopharyngitisAllergic RhinitisNCT06580210Laboratoires Gilbert114
Unknown
不适用
BPK-S Integration (Ceramic) Post Market Clinical Follow-UpRestoration if Knee Joint FunctionNCT03097471Klemens Trieb40
招募中
不适用
ACOART BTK RENEW：A Post Market Clinical StudyPeripheral Artery DiseaseNCT04885985Acotec Scientific Co., Ltd107