A randomised crossover investigation to evaluate and compare the effectiveness, safety and feasibility of a novel dedicated Over-The-Wire FFR Infusion MicroCatheter (HYPEREM IC) for measuring fractional flow reserve (FFR) using intra-coronary non-weight adjusted adenosine infusion with the standard intra-venous administration of adenosine, in subjects with intermediate coronary artery stenosis - A Clinical Investigation to Evaluate the HYPEREM™IC catheter v2

Diasolve Ltd0 个研究点目标入组 44 人开始时间: 2016年3月7日最近更新: 2019年6月30日

试验速览

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•1.Ability and willingness to give written informed consent prior to investigation participation.
•2.Has given consent to undergo hospital’s diagnostic or interventional coronary procedure.
•3.Male or female subject aged 18 and over.
•4.Ability to communicate well with the investigator and to comply with the requirements of the clinical investigation.
•Prior to randomisation:
•1.Coronary angiogram demonstrates at least one coronary stenosis of intermediate severity (40-70%), in a non-infarct related artery, which requires FFR measurement for physiological assessment.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 29

•1.Known sensitivity to adenosine or any of its excipients
•2.Technically inaccessible stenosis(es)
•3.Acute ST segment elevation myocardial infarction (STEMI)
•4.Haemodynamically unstable
•5.Presence of any clinically significant medical condition as determined by the investigator
•6.Pregnancy, including the intention or possibility of becoming pregnant prior to the investigation
•7.Participation in another clinical investigation within the three months prior.

发起方

Diasolve Ltd