Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorGuillermo Galeote; MD, PhD
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous coronary intervention (PCI)
DeviceOptimal stent expansion by IVUS-guided PCI.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: Elective Rotational AtherectomyActive comparator 1 intervention
Group B: Bailout Rotational AtherectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
The costs included the items, supplies, and time used in the catheterization laboratory, and expenses caused by complications during hospital length of stay and 30 days after the procedure.
Time frame
Periprocedural and 30 days after the procedureSecondary outcomes
1
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
During follow-up 5 years.
Time frame
Follow-up 5 years.2
Contrast-induced nephropathy
Contrast-induced nephropathy 48 hours after the procedure.
Time frame
48 hours after the procedure.3
Stent placement success
Defined as expansion with \<20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure
Time frame
Periprocedural4
The amount of angioplasty balloons used in each group before stent deployment.
Number of semi-compliant and non-compliant balloons used during procedure deployment.
Time frame
PeriproceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guillermo Galeote; MD, PhD
Lead sponsor
Hospital Universitario La Paz
Sponsor institution
Source ClinicalTrials.gov