Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutaneous coronary intervention (PCI).
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Chronic Renal Failure. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure
Overview
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.
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 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.
The aim of this study is to compare the healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout). The secondary endpoints were stent placement success (defined as expansion with \<20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure), procedure time, radiation exposure, periprocedural and in-hospital complications, and major cardiovascular adverse events at medium-term follow-up.
Interventions
- Device Percutaneous coronary intervention (PCI)
Optimal stent expansion by IVUS-guided PCI.
Primary outcome measures
- The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout) [Time frame: Periprocedural and 30 days after the procedure]
Secondary outcome measures (8)
- The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout) [Time frame: Follow-up 5 years.]
- Contrast-induced nephropathy [Time frame: 48 hours after the procedure.]
- Stent placement success [Time frame: Periprocedural]
- The amount of angioplasty balloons used in each group before stent deployment. [Time frame: Periprocedural]
- Procedure and fluoroscopy times [Time frame: Periprocedural]
- Periprocedural complications [Time frame: Periprocedural]
- In-hospital complications [Time frame: during hospitalization stay until discharge]
- Major cardiovascular events [Time frame: 1,2,3,4 and 5 years after procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- La Paz University Hospital — Madrid
Identifiers
NCT: NCT05353946 · 00001