Status:
RECRUITING
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
Lead Sponsor:
Guillermo Galeote; MD, PhD
Conditions:
Coronary Artery Disease
Chronic Renal Failure
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 le...
Detailed 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. Severely calcified coronary le...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
February 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 4 2023
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT05353946
Start Date
February 2 2019
End Date
December 4 2023
Last Update
April 29 2022
Active Locations (1)
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1
La Paz University Hospital
Madrid, Spain, 28046