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

Qualifiers

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

Treatments tested in this trial

  • Percutaneous coronary intervention (PCI)

Treatment groups

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Guillermo Galeote; MD, PhD

Lead sponsor

Hospital Universitario La Paz

Sponsor institution