Balloon Angioplasty versus Shockwave Intravascular Lithotripsy for calcified coronary stenosis

Shockwave Medical0 个研究点目标入组 60 人开始时间: 2020年2月3日最近更新: 2023年5月8日

适应症

试验速览

暂无简介。

•Patients undergoing coronary angiography who is found to have significant calcified coronary stenosis are eligible. Coronary artery stenosis is defined by either qualitative or quantitative coronary angiography with more than 60% diameter stenosis in equal or greater than 2.5 mm reference vessel diameter of coronary artery with severe calcification.
•Assessment by intravascular ultrasound (IVUS) with presence of greater than 270° arc of calcification at worst point in lesion. If IVUS cannot be delivered, inclusion can be made by angiographic appearance of heavy calcification.

•Participant is currently enrolled in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
•Participant is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential).
•Participant experienced an acute ST Elevation Myocardial Infarction (STEMI).
•Patient has contraindication to taking dual antiplatelet therapy for a minimum of 6 months.
•Patients in cardiogenic shock.
•Concomitant use of other calcium modification devices prior to randomisation i.e atherectomy, cutting balloons etc.
•Chronic total occlusion

发起方

Shockwave Medical