Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure

Официальное название

CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Percutaneous coronary intervention (PCI)
  Optimal stent expansion by IVUS-guided PCI.

Первичные конечные точки

• The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout) [Срок оценки: Periprocedural and 30 days after the procedure]

Вторичные конечные точки (8)

• The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout) [Срок оценки: Follow-up 5 years.]
• Contrast-induced nephropathy [Срок оценки: 48 hours after the procedure.]
• Stent placement success [Срок оценки: Periprocedural]
• The amount of angioplasty balloons used in each group before stent deployment. [Срок оценки: Periprocedural]
• Procedure and fluoroscopy times [Срок оценки: Periprocedural]
• Periprocedural complications [Срок оценки: Periprocedural]
• In-hospital complications [Срок оценки: during hospitalization stay until discharge]
• Major cardiovascular events [Срок оценки: 1,2,3,4 and 5 years after procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• La Paz University Hospital — Madrid

Идентификаторы

NCT: NCT05353946 · 00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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