Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
Recruiting · NCT05353946 · Interventional (participants receive a specific treatment) · Lead sponsor: Guillermo Galeote; MD, PhD
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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
Where it is running
1 location listed.
- La Paz University Hospital - Madrid, Spain