French Registry to Evaluate the Safety and Efficacy of the Diamondback 360TM Orbital Atherectomy System in the Preparation of Calcified Coronary Lesions Before Implantation of a Coronary Endoprothesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- Safety Endpoint : Major Adverse Cardiac Event (MACE)
研究概览
简要总结
This is a French, prospective, single-arm, multi-center registry to confirm the safety and efficacy of the Diamondback 360 TM Orbital Atherectomy System in the preparation of de novo calcified coronary lesions before implantation of a coronary endoprothesis in adult subjects. The primary safety endpoint is 30-day MACE and the efficacy endpoint is procedural success.
详细描述
Treatment of calcified lesions, caused in 6 to 20% of patients, remains a challenge.
Presence of coronary calcifications complicates stent placement resulting in up to 50% malapposition or under-expansion of the stent and is associated with a higher frequency of major adverse cardiac events (MACE).
In order to reduce these risks, preparation of these lesions before the implantation of a coronary stent is essential. The arrival on the European market of a new Orbital atherectomy system leads to consider its use in the preparation of such lesions.
The orbital atherectomy system uses a diamond-coated eccentric crown that abrades calcified plaque and develops pulsatile forces on the wall. It reduces calcified plaque and modifies plaque with fractures, facilitating stent placement and allowing for optimal stent expansion.
ORBIT I and ORBIT II clinical trials were conducted in the United States to evaluate the safety of using the Orbital Atherectomy System in de novo calcified coronary lesions in adults. These 2 trials demonstrated that orbital atherectomy not only facilitated stenting, but also improved clinical outcomes compared to historical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Subjects ≥ 18 years
- •Patients with a clinical indication for coronary angioplasty and presenting a de novo calcified lesion
- •The target vessel reference diameter must be >= 2.5mm and <= 4.0 mm.
- •Lesion length <= 40 mm
- •The target vessel must be a coronary artery with a stenosis of >70%
- •Patients able to understand and provide informed consent
- •Patients with Social Security coverage
排除标准
- •Patients with an LVEF < 25%.
- •Patient with hypersensitivity to egg, soy or peanut proteins or to one of the active substances or one of the excipients of ViperSlide lubricant.
- •Pregnant or breastfeeding woman
- •Unwilling or unable to sign the Informed Consent
- •Patients under judicial protection, tutorship or curatorship
- •Angiographic criteria: Intra-stent stenosis, Presence of a chronic total occlusion (CTO), Bypass lesion, Target vessel excessively tortuous, Presence of a thrombus, Presence of a single permeable vessel
结局指标
主要结局
Safety Endpoint : Major Adverse Cardiac Event (MACE)
时间窗: 30 days
The Diamondback 360°® Orbital Atherectomy System safety was evaluated by a composite of MACE at 30-days post procedure. MACE is composed of : * Myocardial infarction : Type I and/or Type IV * TVR - defined as revascularization at the target vessel after the completion of the index procedure. * Cardiac death.
次要结局
- Safety Endpoint : 12 Month MACE(12 months)
- Efficacy Endpoint : Revascularization success rate(Until hospital discharge after index procedure, average estimated at 48 hours)
- Safety endpoint : Comparison of MACE with rotational atherectomy(30 days)