Coronary Chronic Total Occlusion Percutaneous Coronary Intervention Using Antegrade Wiring Strategy With a First-choice Gladius Guidewire: a Randomized Clinical Study (Gladius First Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- time-efficiency of antegrade wiring strategy
研究概览
简要总结
The Gladius First trial is designed as a single-centre, open, prospective, randomized clinical trial aimed to assess the efficiency and safety of coronary chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using the antegrade wiring strategy with a first-choice intermediate Gladius guidewire. To this end, consecutive patients referred to CTO PCI with intended primary antegrade wire escalation strategy, will be randomized in a 1:1 fashion to antegrade wiring starting with the Gladius guidewire or antegrade wiring using the standard guidewire escalation strategy.
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
- •delivery of an informed consent and compliance with study protocol
- •CTO of a major coronary artery with at least intermediate difficulty score (J-CTO ≥1) as assessed by invasive angiography
- •referral to clinically indicated CTO PCI with intended primary antegrade wiring strategy
排除标准
- •in-stent CTO
- •unstable angina and/or myocardial infarction
- •prior myocardial infarction within 4 weeks before study enrolment
- •CTO of a major coronary artery with an easy difficulty score (J-CTO 0) as assessed by invasive coronary angiography
- •lack of valid antegrade wire escalation strategy as assessed by 2 independent CTO PCI operators
- •chronic kidney disease (defined as eGFR ≤30 ml/min/m2)
- •contraindication to antiplatelet therapy and/or heparin
- •severe inflammatory disease
- •positive pregnancy test or breast-feeding
研究组 & 干预措施
CTO PCI using antegrade wiring strategy starting with the Gladius guidewire
Study subjects will undergo CTO PCI with primary antegrade wiring strategy starting with the Gladius guidewire. In case of failed CTO crossing with the Gladius wire, the decision on continuing antegrade wire escalation with a different wire or switching to a different CTO PCI strategy will be left to the discretion of the operator.
干预措施: CTO PCI with the first-choice Gladius guidewire (Procedure)
CTO PCI using standard antegrade wire escalation strategy
Control subjects will undergo CTO PCI using standard antegrade wiring strategy starting with the lower/intermediate penetration force guidewires and, if necessary, escalating up to high gram-force guidewires, but without the use of first-choice Gladius guidewire.
干预措施: CTO PCI without the first-choice Gladius guidewire (Procedure)
结局指标
主要结局
time-efficiency of antegrade wiring strategy
时间窗: during procedure (intraprocedural)
time-efficiency of antegrade wiring strategy defined as the time from advancement of the first wire into the proximal cap to either the time of successful antegrade wiring through the lesion or the time of cessation of antegrade wiring and changing CTO PCI strategy according to the hybrid algorithm
次要结局
- time-efficiency of successful antegrade wiring strategy(during procedure (intraprocedural))
- time-efficiency of successful antegrade approach(during procedure (intraprocedural))
- total procedural time(during procedure (intraprocedural))
- contrast volume related to successful guidewire crossing through CTO using antegrade wiring strategy(during procedure (intraprocedural))
- total contrast volume(during procedure (intraprocedural))
- incidence of periprocedural complications(during hospitalization (assessed up to 30 days))
- time-efficiency of antegrade approach(during procedure (intraprocedural))
- time-efficiency of successful CTO recanalization using any technique(during procedure (intraprocedural))
- successful guidewire crossing through CTO with restoration of flow using antegrade wiring strategy(during procedure (intraprocedural))
- successful guidewire crossing through CTO using antegrade wiring strategy(during procedure (intraprocedural))
- successful guidewire crossing through CTO using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)(during procedure (intraprocedural))
- total radiation dose(during procedure (intraprocedural))
- successful guidewire crossing through CTO with restoration of flow using antegrade approach (including antegrade wiring and antegrade dissection and re-entry strategies)(during procedure (intraprocedural))
- final procedural success defined as successful guidewire crossing through CTO with restoration of flow(during procedure (intraprocedural))
- radiation dose related to successful guidewire crossing through CTO using antegrade wiring strategy(during procedure (intraprocedural))