Study Comparing Elective Versus Bailout Rotational Atherectomy for Severe Coronary Artery Calcification in Patients with Chronic Kidney Disease

What this Trial Is About

Researchers are studying the use of rotational atherectomy in patients with severely calcified coronary artery lesions, especially those with chronic kidney disease, which is linked to more severe arterial calcification. The study aims to compare the healthcare costs and outcomes between elective rotational atherectomy and conventional angioplasty bailout in this patient group, as there is currently no direct randomized comparison using intravascular ultrasound to assess calcification severity. Participants will be randomly assigned to either receive elective rotational atherectomy or start with conventional angioplasty, with rotational atherectomy used only if needed as a bailout. The procedure uses a Rotablator system that rotates a diamond-coated burr to remove calcified plaque, followed by intravascular ultrasound-guided stent placement. The study evaluates costs, success of stent expansion, procedure time, radiation exposure, complications, and cardiovascular events over medium-term follow-up. During the study, participants will undergo detailed imaging with intravascular ultrasound, angioplasty, and stent placement procedures. Researchers will monitor healthcare costs up to 30 days and over 5 years, procedure and fluoroscopy times, contrast-induced kidney injury, periprocedural and in-hospital complications, and major cardiovascular events up to 5 years after the procedure. The total participation duration includes these follow-up periods to assess safety and outcomes.

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