Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 20
- 主要终点
- NACE (Net Adverse Clinical Events)
研究概览
简要总结
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.
详细描述
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all inclusion criteria:
- •Patients with Signed informed consent and
- •Patients with >=18 years old and
- •Patients with chronically receiving oral anticoagulation treatment with any type of anticoagulant for any reason and
- •Patients with de novo Coronary artery disease requiring both elective or urgent percutaneous revascularization due to stable coronary artery disease or acute coronary syndrome with or without ST-segment elevation, and in which an ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer has been used
排除标准
- •Patients do not have to meet any exclusion criteria
- •Patients treated percutaneously with any type of stent other than the SupraFlex Cruz® in the 6 months prior to the index procedure in which he or she is included.
- •Use in the same procedure or in a scheduled procedure of other stents different from the one evaluated for the treatment of another vessel(s).
- •Patients treatment for restenosis or stent thrombosis.
- •Patients presentation in cardiogenic shock or after cardiorespiratory arrest.
- •Patients with allergy to any of the components of the stent to be used.
- •Patients with impossibility for follow-up.
- •Patients with life expectancy less than 1 year.
研究组 & 干预措施
Supraflex Cruz Sirolimus-eluting Stent
干预措施: Supraflex Cruz Sirolimus-eluting Stent (Device)
结局指标
主要结局
NACE (Net Adverse Clinical Events)
时间窗: 12 month
Combined endpoint of Cardiac Death, Acute Myocardial Infarction, Stroke, Need for new Treated Vessel Revascularization (TVR) and BARC (Bleeding Academic Research Consortium) 3-5
次要结局
- MACE (Major Adverse Cardiac Events)(6 months)
- TLF (Target Lesion Failure)(6 months)
- Death(6 months)
- Acute Myocardial Infarction (AMI)(6 months)
- Stroke(6 months)
- Target vessel revascularization (TVR)(6 months)
- Death(12 months)
- MACE (Major Adverse Cardiac Events)(12 months)
- TLF (Target Lesion Failure)(12 months)
- Acute Myocardial Infarction (AMI)(12 months)
- Stroke(12 months)
- Target vessel revascularization (TVR)(12 months)