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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Absence of willing to sign a consent form. - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Percutaneous coronary intervention (PCI)

Optimal stent expansion by IVUS-guided PCI.

Locations (1)

La Paz University Hospital
Madrid, Spain