Actively Recruiting
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
Led by Guillermo Galeote; MD, PhD · Updated on 2022-04-29
124
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old
- Glomerular filtration rate (GFR) less than 60 mL/min/1.73 m2 for 3 months or more
- Coronary artery stenosis of 70% or more in a vessel with diameter 2.5 mm or larger
- Severe angiographic calcification affecting both sides of the arterial lumen
- Any clinical scenario except acute myocardial infarction in the first seven days
- Lesion in native coronary vessel or bypass graft
You will not qualify if you...
- 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 greater than 60 degrees, dissections, lesions with thrombus, or degenerated saphenous vein grafts
- Hemodynamically unstable patients
- Allergy to iodinated contrast media
- Significant comorbidity with life expectancy less than one year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
La Paz University Hospital
Madrid, Spain, 28046
Actively Recruiting
Research Team
G
Guillermo Galeote, PhD, MD
CONTACT
A
Artemio García-Escobar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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