ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions, the SONAR Trial. ;A randomized controlled trial comparing rates of peri-procedural myocardial infarction after intravascular ultrasound and rotational atherectomy in patients with calcified coronary artery lesions. - the SONAR Trial

Z Leuven0 个研究点目标入组 65 人开始时间: 待定最近更新: 2024年4月9日

试验速览

暂无简介。

•Patient older than 18 years.
•The subject has stable or unstable angina pectoris, or a positive functional
•study for ischemia.
•The subject is eligible for PCI.
•The subject gives consent prior to study inclusion.
•The subject has a moderate to severe calcified lesion with the expected need of
•plaque modification, on the condition that with or without low profile balloon
•(<= 1.5 mm) preparation, a >= 2.5 non-compliant balloon can cross the lesion.
•The calcified lesion has a 50-90% diameter stenosis by angiographic assessment.

•Previous and/or planned brachytherapy of target vessel.
•Pregnant and/or breast-feeding females or females who intend to become pregnant.
•Patients who intend to have a major surgical intervention within 6 months of
•enrolment in the study.
•Patients who previously participated in this study.
•Subject has experienced an acute myocardial infarction 72 hours prior to the
•index procedure, as defined either by the presence of a new Q-wave in 2 or more
•contiguous leads, or by a CK greater than two times site upper reference limit
•(URL) with presence of CK-MB greater than the site URL.
•The subject has suffered a stroke or transient ischemic neurological attack or
•cerebrovascular accident within the past six months, or has any known
•intracranial mass, arteriovenous malformation, aneurysm or other intracranial
•The subject has experienced a significant gastrointestinal or genitourinary
•bleed within the past six months, or has had any active bleeding within two
•Planned revascularization of target vessel within 1 year after index procedure.
•Lesions not ideal for Shockwave treatment:
•Longer than 40mm.
•The target vessel contains intraluminal thrombus.
•The subject has had a prior stent in the target lesion, including a 5mm zone
•proximal and distal to the lesion.

发起方

Z Leuven