A Randomized Comparison Between Transfemoral Approach With Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Major vascular access site complications
研究概览
简要总结
Primary percutaneous coronary intervention represents the gold standard for the treatment of ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are associated with an increased risk of mortality, re-infarction, and stroke. Although the prognostic value of access site related bleeding complications is still debated, transradial approach is associated with better short-term outcomes and reduced hospital stay as compared to transfemoral approach. The investigators aimed to compare transradial approach with transfemoral approach with systematic achievement of hemostasis by the implantation of a vascular closure device in a national multicentre randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
- •Intention to perform primary percutaneous coronary intervention;
- •Signed informed consent;
- •Patient eligible for transradial and transfemoral primary percutaneous coronary intervention, being pre-requisites: (a) familiarity of the operator with the radial and femoral techniques using vascular closure devices, (b) agreement of the operator to use the access route determined by the randomization process.
排除标准
- •Less than 18 years of age;
- •Pregnancy;
- •Chronic use of vitamin K antagonists or direct thrombin inhibitors, or oral Xa-factor antagonists;
- •Hypersensitivity to antiplatelet and/or anticoagulant drugs;
- •Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance < 30 mL/min, platelets count < 100.000 mm3);
- •Uncontrolled systemic hypertension;
- •Cardiogenic shock;
- •Previous myocardial revascularization surgery with ≥ 1 internal mammary or radial artery graft;
- •Documented chronic peripheral arterial disease preventing the use of the femoral technique;
- •Severe concomitant disease with life expectancy below 12 months;
- •Participation in drug or devices investigative clinical trials in the last 30 days;
- •Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.
结局指标
主要结局
Major vascular access site complications
时间窗: 48 hours post-procedure
Major vascular complications related to arterial access site will be evaluated during hospitalization by physical examination and duplex ultrassonography and include major bleeding, retroperitoneal hemorrhage, compartment syndrome, pseudoaneurysm, arteriovenous fistula, limb ischemia or need for vascular surgery repair.
次要结局
- Device success(48 hours post-procedure)
研究者
Pedro Beraldo de Andrade
MD, phD
Irmandade Santa Casa Misericórdia Marília