Svelte SOAW Coronary Stent Clinical Observational Study - Svelte SOAW

Svelte Medical Systems, Inc0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Patient >18 years old.
•- Eligible for percutaneous coronary intervention (PCI).
•- Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
•- Patient is willing to comply with specified follow-up evaluation.
•- Acceptable candidate for coronary artery bypass graft (CABG) surgery.
•- (un)stable angina pectoris or a positive functional ischemia study.
•- Male or non-pregnant female patient of non child-bearing potential.
•- A number of specific Angiographic Inclusion Criteria (see protocol).

•- Currently enrolled in another trial that has not completed the primary endpoint.
•- A previous coronary interventional procedure < 30 days prior to the procedure.
•- The patient requires a staged procedure within 30 days post-procedure.
•- The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
•- Previous bare metal stent (BMS) deployment anywhere in the target vessel within the past 6 months.
•- Any DES deployment anywhere in the target vessel within the past 9 months.
•- Co-morbid condition(s) that could limit the patient*s ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
•- Concurrent medical condition with a life expectancy of <12 months.
•- Documented LVEF < 30% at the most recent evaluation.
•- Evidence of an AMI within 72 hours of the intended trial procedure.
•- History of cerebrovascular accident or TIA <6 months.
•- Specific Angiographic Exclusion Criteria, incl left main lesion (see protocol)

发起方