Clinical trial NCT05353946: Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
Official title: CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Chronic Renal Failure
Keywords: Severely calcified coronary lesion
Rotational atherectomy
Chronic kidney disease
Intravascular ultrasound
Percutaneous coronary intervention
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

The aim of this study is to compare the healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout). The secondary endpoints were stent placement success (defined as expansion with \<20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure), procedure time, radiation exposure, periprocedural and in-hospital complications, and major cardiovascular adverse events at medium-term follow-up.

Eligibility 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

Primary outcomes:
measure: The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
timeFrame: Periprocedural and 30 days after the procedure
Secondary outcomes:
measure: The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
timeFrame: Follow-up 5 years.
measure: Contrast-induced nephropathy
timeFrame: 48 hours after the procedure.
measure: Stent placement success
timeFrame: Periprocedural
measure: The amount of angioplasty balloons used in each group before stent deployment.
timeFrame: Periprocedural
measure: Procedure and fluoroscopy times
timeFrame: Periprocedural
measure: Periprocedural complications
timeFrame: Periprocedural
measure: In-hospital complications
timeFrame: during hospitalization stay until discharge
measure: Major cardiovascular events
timeFrame: 1,2,3,4 and 5 years after procedure
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: La Paz University Hospital
name: Guillermo Galeote, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: