Compares two timings of rotational atherectomy for calcified heart arteries in kidney failure
Compares planned versus backup use of rotational atherectomy in adults with hard heart arteries.
Plain-language title generated from the registry record
Registry title: Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
Key facts
- Where
- Madrid, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT05353946, who can take part
Where in Spain
- La Paz University HospitalMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guillermo Galeote; MD, PhD
- Trial code
- NCT05353946
- Record updated
- 29 April 2022
- Original description
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.Read full original descriptionShow less
CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure
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.
Inclusion: 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: Acute myocardial infarction in the first 7 days of evolution; Patients with allergy to iodinated contrast media; Absence of informed consent; 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 significant comorbidity and with a life expectancy of less than one year.