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

RecruitingNAAges 18 Years - 100 YearsAllGuillermo Galeote; MD, PhD
NCT05353946 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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What it tests

  • Percutaneous coronary intervention (PCI)
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Where

1 site
La Paz University Hospital
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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