跳至主要内容
临床试验/CTRI/2023/10/058946
CTRI/2023/10/058946尚未招募Unknown

A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study toevaluate the safety and performance of Vector® NC PTCA Balloon Catheter in real-world settings.

Sahajanand Laser Technology Ltd2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2023年10月28日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
125
试验地点
2
主要终点
Procedure Success

研究概览

简要总结

A retrospective,  single-arm, multi-center,  observational, post-market clinical  follow-up  study  to  evaluate the  safety  and performance  of Vector NC PTCA Balloon CatheterThe Vector NC PTCA Balloon Catheter is also indicated for post-deliveryexpansion of balloon expandable stents. All consecutive patients who had beentreated with Vector NC PTCA Balloon Catheter for balloon dilatation of stenoticportion of coronary artery or by pass graft stenosis for improving myocardialperfusion and/or post-delivery expansion of balloon expandable stents. Thestudy Population is about 125 patients and The objective of this study is toevaluate the safety and performance of Vector NC PTCA Balloon Catheter inreal-world settings.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients who had been treated with Vector NC PTCA Balloon Catheter.

排除标准

  • 未提供

结局指标

主要结局

Procedure Success

时间窗: Peri-Procedural

次要结局

  • Target lesion revascularization(Myocardial Infraction)

研究者

发起方
Sahajanand Laser Technology Ltd
申办方类型
Other [Medical Device ]

研究点 (2)

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