CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
研究概览
简要总结
The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.
Severely calcified coronary lesions are associated with worse outcomes. In this regard, chronic kidney disease is associated with severely calcified coronary arteries.
Some evidence suggests that elective rotational atherectomy used by experienced operators can be safe and effective, minimizing time and complications for patients with heavily calcified lesions.
However, there is no direct randomized comparison between rotational atherectomy and angioplasty alone in the setting of chronic renal failure and with intravascular ultrasound assessment for detecting severely calcified coronary arteries.
详细描述
The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.
Severely calcified coronary lesions are associated with worse outcomes. In this regard, chronic kidney disease is associated with severely calcified coronary arteries.
Some evidence suggests that elective rotational atherectomy used by experienced operators can be safe and effective, minimizing time and complications for patients with heavily calcified lesions.
However, there is no direct randomized comparison between rotational atherectomy and angioplasty alone in the setting of chronic renal failure and with intravascular ultrasound assessment for detecting severely calcified coronary arteries.
The aim of this study is to compare the healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout). The secondary endpoints were stent placement success (defined as expansion with <20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure), procedure time, radiation exposure, periprocedural and in-hospital complications, and major cardiovascular adverse events at medium-term follow-up.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years.
- •Glomerular filtration rate (GFR) <60 mL/min/1.73 m2 for 3 months or more
- •Stenosis ≥70% in a coronary artery with a diameter ≥2,5 mm.
- •Severe angiographic calcification (affecting both sides of the arterial lumen)
- •Any clinical scenario except acute myocardial infarction in the first seven days of evolution.
- •Native coronary vessel or bypass graft.
排除标准
- •Absence of informed consent.
- •Acute myocardial infarction in the first 7 days of evolution.
- •Lesion in a single patent vessel.
- •Calcified lesions with an angulation >60º, dissections, lesions with thrombus, and degenerated saphenous vein grafts.
- •Hemodynamically unstable patients
- •Patients with allergy to iodinated contrast media
- •Patients with significant comorbidity and with a life expectancy of less than one year
研究组 & 干预措施
Bailout Rotational Atherectomy
The operators began with conventional angioplasty (non-compliant balloon dilatation) regardless of the calcification patterns in the coronary lesion, and rotational atherectomy (RA) can be used only as a bailout.
干预措施: Percutaneous coronary intervention (PCI) (Device)
Elective Rotational Atherectomy
Operators can decide elective use of rotational atherectomy (RA) or conventional angioplasty according to the calcification patterns of the coronary lesion evaluated by Intravascular ultrasound (IVUS) or by angiography if the IVUS cannot cross the lesion.
Procedure is performed with a Rotablator system, consisting of a rotating olive-shaped burr whose leading hemisphere is coated with microscopic diamond chips. The proximal end of the device has a housing unit containing the burr advancer, a fiberoptic tachometer cable, an irrigation port, and a nitrogen gas delivery hose, which permits the rapidly rotating of the burr. The RA catheter is introduced into the coronary artery over a stainless steel 0.09-inch wire to cross the lesion, then advanced with a slow pecking motion at a speed of 160,000 to 190,000 rpm with each ablation run <15 seconds is performed. Burr size was with a burr/vessel ratio of 0.7. After RA, all patients received IVUS-guided percutaneous coronary intervention.
干预措施: Percutaneous coronary intervention (PCI) (Device)
结局指标
主要结局
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
时间窗: Periprocedural and 30 days after the procedure
The costs included the items, supplies, and time used in the catheterization laboratory, and expenses caused by complications during hospital length of stay and 30 days after the procedure.
次要结局
- The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)(Follow-up 5 years.)
- Contrast-induced nephropathy(48 hours after the procedure.)
- Stent placement success(Periprocedural)
- Periprocedural complications(Periprocedural)
- The amount of angioplasty balloons used in each group before stent deployment.(Periprocedural)
- In-hospital complications(during hospitalization stay until discharge)
- Procedure and fluoroscopy times(Periprocedural)
- Major cardiovascular events(1,2,3,4 and 5 years after procedure)
研究者
Guillermo Galeote; MD, PhD
Principal Investigator
Hospital Universitario La Paz