Prospective, Single-arm, Multicenter, Observational, Prospective Registry of RESOLUTE-ONYX™ Zotarolimus-eluting Stent Utilization in Percutaneous Small Vessel Coronary Interventionism.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 307
- 试验地点
- 15
- 主要终点
- Incidence of Major Adverse Cardiac Events (MACE)
研究概览
简要总结
DESIGN: Prospective, single-arm, multicenter, observational, prospective registry of the use of the RESOLUTE-ONYX™ zotarolimus-eluting stent in percutaneous coronary intervention in small vessels.
Clinical follow-up at 1 month, 6 months and 1 year.
OBJECTIVE: To evaluate the safety and efficacy of using RESOLUTE-ONYX zotarolimus-eluting stent in PCI in small vessels (diameter ≤2.5 mm).
DISEASE UNDER STUDY: Adult patients with coronary artery disease (stable angina, silent ischemia or non-ST-segment elevation acute coronary syndrome) undergoing percutaneous coronary intervention on vessels with a diameter less than or equal to 2.5 mm.
TOTAL NUMBER OF PATIENTS: Approximately 320 patients are expected to be included in the study.
详细描述
1.1 STUDY TITLE:
Prospective, single-arm, multicenter, observational, prospective registry of use of the RESOLUTE-ONYX™ zotarolimus-eluting stent in percutaneous small vessel coronary intervention (DISCO 9 study).
1.2 SPONSOR:
Fundación de Investigación Sanitaria en León (FISLeón) Complejo Asistencial Universitario de León.
Altos de Nava s/n 24008 León. SPAIN.
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
- •Signature of the Informed Consent in writing.
- •Patients over 18 years of age.
- •Males or post-menopausal women or women under contraceptive treatment. Women of childbearing age must have a negative pregnancy test.
- •Diagnosis of stable angina, silent ischemia or non-ST-segment elevation acute coronary syndrome (unstable angina or non-Q infarction).
- •De novo coronary artery disease, single-vessel or multivessel, with stenosis >70% according to visual estimation, susceptible to treatment with intracoronary stenting.
- •Coronary stenosis involving a vessel with diameter ≥2 mm and ≤2.5 mm.
- •Implantation of the RESOLUTE-ONYX™ zotarolimus-eluting stent used according to the indications for use in routine clinical practice at the center.
排除标准
- •Acute myocardial infarction with ST-segment elevation during the hospitalization in which the patient is included.
- •Significant stenosis of the left coronary artery trunk.
- •In-stent restenosis.
- •Chronic total occlusion.
- •Stenosis in aorto-coronary grafts of saphenous vein or mammary or radial artery.
- •Hemorrhagic diathesis or high risk of bleeding.
- •Treatment with oral anticoagulants.
- •Allergy to aspirin, clopidogrel, prasugrel or ticagrelor.
- •Known allergy to zotarolimus, nickel, chromium, or cobalt.
- •Women who are pregnant, breastfeeding or expect to become pregnant within the next year.
- •Participation in another clinical study.
- •Limited life expectancy (< 1 year).
- •Planned major elective surgery
- •Unable to complete follow-up.
结局指标
主要结局
Incidence of Major Adverse Cardiac Events (MACE)
时间窗: 1 year
Incidence of Major Adverse Cardiac Events (MACE) defined as a composite of: death of cardiac origin, target vessel-related myocardial infarction and/or new target lesion revascularization (percutaneous or surgical).
次要结局
- Each of the separate components of the combined event: Death of cardiac origin, target vessel-related myocardial infarction, new target lesion revascularization (percutaneous or surgical)(1 month, 6 months, 1 year.)
- Bleeding unrelated to surgical revascularization(1 month, 6 months, 1 year)
- Success of the procedure(In the procedure)
- Acute/sub-acute thrombosis(1 month, 6 months, 1 year)
- Periprocedural myocardial infarction(In the procedure)
- Duration of dual antiplatelet therapy(1 month, 6 months, 1 year)