RecruitingNot ApplicableNCT05353946

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

CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure

Sponsor

Guillermo Galeote; MD, PhD

Enrollment

124 participants

Start Date

Feb 2, 2019

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease Chronic Renal Failure

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to treating severely calcified (hardened) coronary artery blockages in patients with chronic kidney disease: using a rotational tool (atherectomy) as a planned first step versus only using it as a backup when standard balloon treatment fails. **You may be eligible if...** - You are older than 18 - You have chronic kidney disease (GFR below 60 mL/min for at least 3 months) - You have a coronary artery stenosis (blockage) of 70% or more in an artery at least 2.5mm wide - Your artery has severe calcification on both sides of the vessel wall - You are having this procedure outside of the first 7 days of a heart attack **You may NOT be eligible if...** - You are in the first 7 days following a heart attack - You have only one functioning coronary vessel (single patent vessel) - Your blockage has specific features that make atherectomy unsafe (extreme angles, dissections, clot, or degenerated vein graft) - You are hemodynamically unstable - You are allergic to iodinated contrast dye - Your life expectancy is less than one year due to other illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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