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Clinical trial Recruiting at 1 site Interventional Ages 18 to 100

Planned versus bailout rotational atherectomy for heavily calcified coronary blockages in people with chronic kidney disease

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

Run by Hospital Universitario La Paz · NCT05353946 · Data updated 2026-11-12

This study will see if doing planned rotational atherectomy before stenting works better than using it only as a bailout during angioplasty for people with severe calcified coronary blockages and chronic kidney disease.

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Quick facts

Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment124 (estimated)
SponsorHospital Universitario La Paz
Academic / other
Drugs / interventionsradiation
Locations1 site (Madrid)
StatusRecruiting
StartedFebruary 2, 2019
Main results expectedDecember 27, 2022
Study endsDecember 4, 2023
Registry record updatedApril 29, 2022
Trial IDNCT05353946 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults over 18 with chronic kidney disease (GFR <60 mL/min/1.73 m2 for ≥3 months) who have a native or graft coronary stenosis ≥70% in a vessel ≥2.5 mm with severe angiographic calcification and no acute myocardial infarction within the prior seven days are ideal candidates.

Probably not a fit

Patients with recent (within 7 days) myocardial infarction, a single patent vessel, severely angulated calcified lesions (>60°), thrombus or dissection at the lesion, degenerated vein grafts, hemodynamic instability, iodinated contrast allergy, or life expectancy under one year are unlikely to benefit or are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial compares elective (planned) rotational atherectomy versus rotational atherectomy used only as a bailout during percutaneous coronary intervention in patients with chronic renal failure and severely calcified coronary lesions confirmed by intravascular ultrasound. Participants are adults with chronic kidney disease (GFR <60 mL/min/1.73 m2 for at least 3 months) and significant stenosis (≥70%) in vessels ≥2.5 mm. The primary analysis focuses on healthcare cost differences between strategies, with secondary endpoints including IVUS-defined stent expansion (<20% residual stenosis), procedure time, radiation exposure, periprocedural and in-hospital complications, and medium-term major cardiovascular events. Procedures are performed by experienced operators at La Paz University Hospital with standardized IVUS assessment and predefined exclusion criteria to reduce high-risk anatomy or unstable patients.

Why it matters

Potential benefit: If successful, planned rotational atherectomy could improve stent expansion and reduce complications, procedure time, and overall costs for CKD patients with heavily calcified coronary arteries.

How similar studies have gone: Non-randomized and operator-experience reports suggest elective rotational atherectomy can be safe and effective for heavily calcified lesions, but randomized comparisons specifically in chronic kidney disease patients with IVUS guidance are lacking.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • La Paz University Hospital
    Madrid, Spain     Recruiting

Study contacts

  • Principal investigator: Guillermo Galeote, PhD, MD — La Paz University Hospital
  • Study coordinator: Guillermo Galeote, PhD, MD
  • Email: ggaleote1@gmail.com
  • Phone: +34609024315

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Coronary Artery Disease 385Chronic Renal Failure 4Hospital Universitario La Paz 7
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.