Self-exPAndable Coronary stentIng in subacute and chrOnic total occlusions; a pilot study - SPACIOUS

Albert Schweitzer Ziekenhuis0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Patient with a total or subtotal occlusion as evidenced by angiography and under optimal drug regimen amenable for revascularization.
•2. Subject >=18 years.
•3. Reference vessel diameter >=2.5mm and <=6mm preferably measured by QCA, or if QCA not possible by visual estimate.
•4. Subject understands the nature of the procedure and provides written informed consent prior to the procedure.
•5. Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone

•1. Acute coronary syndromes, but not post-infarction AP
•2. Cardiogenic shock.
•3. Any vasculature lesions or characteristics preventing PCI, introduction of the STENTYS delivery system or placement of the STENTYS Stent.
•4. Allergies or contraindications to antiplatelet medication, contrast or to stent components which cannot be adequately treated.
•5. Female patient with child bearing potential not taking adequate contraceptives.
•6. Participation in another investigational drug or device study in which the primary endpoint has not been reached yet and that interferes with this study.

发起方