Planned versus bailout rotational atherectomy for heavily calcified coronary blockages in people with chronic kidney disease
CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure
NA · Hospital Universitario La Paz · NCT05353946
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Hospital Universitario La Paz (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05353946 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Chronic Renal Failure, Severely calcified coronary lesion, Rotational atherectomy, Chronic kidney disease, Intravascular ultrasound, Percutaneous coronary intervention