Ireland
--:--IST
Recruiting Not applicable

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

NCT05353946 · tracked via the Priya Life Science Spain tracker
Sponsor
Guillermo Galeote; MD, PhD
Phase
Not applicable
Started
2019-02-02
Last updated
2022-04-29

Condition(s) studied

Coronary Artery DiseaseChronic Renal Failure

Investigational drug(s) / intervention(s)

Percutaneous coronary intervention (PCI)

Percutaneous coronary intervention (PCI): Optimal stent expansion by IVUS-guided PCI.

Study 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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout) — Periprocedural and 30 days after the procedure
    The costs included the items, supplies, and time used in the catheterization laboratory, and expenses caused by complications during hospital length of stay and 30 days after the procedure.

Trial sites (1)

FacilityCityRegionStatus
La Paz University Hospital Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05353946 on ClinicalTrials.gov ↗ ← All trials in Spain