Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure (CRATER)

  • STATUS
    Recruiting
  • End date
    Dec 4, 2023
  • participants needed
    124
  • sponsor
    Guillermo Galeote; MD, PhD
Updated on 12 May 2022
stenosis
myocardial infarction
infarct
percutaneous coronary intervention
bypass graft
intravascular ultrasound

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 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.

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.

Details
Condition Coronary Artery Disease, Chronic Renal Failure
Treatment Percutaneous Coronary Intervention (PCI)
Clinical Study IdentifierNCT05353946
SponsorGuillermo Galeote; MD, PhD
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
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