An Observational Safety Evaluation of patients treated with the NEVO* Sirolimus-eluting Coronary Stent. - NEVO II study

Johnson & Johnson0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Subject has atherosclerotic coronary artery disease with an indication for stent implantation;
•2. Target lesion(s) with a diameter stenosis of minimally 50% (visual estimate) OR a functional study documenting the hemodynamic relevance of the target lesion(s);
•3. All target lesion(s) require treatment with stents having diameters from 2.5mm to 3.5mm (visual estimate);
•4. Subject is >=18 years of age;
•5. Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure;
•6. Subject must be willing and able to comply with specified follow-up schedule.

•1. Planned medical procedures or concomitant disease requiring modification of DAPT regimen within 6 months of enrollment into this study;
•2. Women of childbearing potential without negative pregnancy test within 7 days before enrollment OR women who do not agree to remain on birth control until angiographic follow-up at 13 months if applicable OR lactating women. For women of childbearing potential, requiring an acute, non-elective procedure, a verbal confirmation of non pregnancy and birth control is sufficient;
•3. Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints.

发起方