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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Chronic Renal Failure
• Intervention / Treatment: Device: Percutaneous coronary intervention (PCI)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillermo Galeote, PhD, MD; Phone Number: +34609024315; Email: ggaleote1@gmail.com
• Study Contact Backup: Name: Artemio García-Escobar, MD; Phone Number: +34608936547; Email: dr_garciaescobar@hotmail.com

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • La Paz University Hospital
    • Contact: Guillermo Galeote, PhD, MD; Phone Number: +34609024315; Email: ggaleote1@gmail.com
    • Contact: Artemio García-Escobar, MD; Phone Number: +34608936547; Email: dr_garciaescobar@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Elective Rotational Atherectomy; Operators can decide elective use of rotational atherectomy (RA) or conventional angioplasty according to the calcification patterns of the coronary lesion evaluated by Intravascular ultrasound (IVUS) or by angiography if the IVUS cannot cross the lesion. Procedure is performed with a Rotablator system, consisting of a rotating olive-shaped burr whose leading hemisphere is coated with microscopic diamond chips. The proximal end of the device has a housing unit containing the burr advancer, a fiberoptic tachometer cable, an irrigation port, and a nitrogen gas delivery hose, which permits the rapidly rotating of the burr. The RA catheter is introduced into the coronary artery over a stainless steel 0.09-inch wire to cross the lesion, then advanced with a slow pecking motion at a speed of 160,000 to 190,000 rpm with each ablation run <15 seconds is performed. Burr size was with a burr/vessel ratio of 0.7. After RA, all patients received IVUS-guided percutaneous coronary intervention.	Device: Percutaneous coronary intervention (PCI); Optimal stent expansion by IVUS-guided PCI.
Active Comparator: Bailout Rotational Atherectomy; The operators began with conventional angioplasty (non-compliant balloon dilatation) regardless of the calcification patterns in the coronary lesion, and rotational atherectomy (RA) can be used only as a bailout.	Device: Percutaneous coronary intervention (PCI); Optimal stent expansion by IVUS-guided PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)	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.	Periprocedural and 30 days after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)	During follow-up 5 years.	Follow-up 5 years.
Contrast-induced nephropathy	Contrast-induced nephropathy 48 hours after the procedure.	48 hours after the procedure.
Stent placement success	Defined as expansion with <20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure	Periprocedural
The amount of angioplasty balloons used in each group before stent deployment.	Number of semi-compliant and non-compliant balloons used during procedure deployment.	Periprocedural
Procedure and fluoroscopy times	Measured in minutes	Periprocedural
Periprocedural complications	Coronary dissection (NHLBI classification system), coronary perforation (Ellis classification system), no-reflow phenomenon (defined as less than TIMI 3 flow), and side branch occlusion	Periprocedural
In-hospital complications	Target lesion revascularization, target vessel revascularization, non-target vessel revascularization, stent thrombosis, vascular complications, and death	during hospitalization stay until discharge
Major cardiovascular events	Death, myocardial infarction, target lesion revascularization, target vessel revascularization, and non-target vessel revascularization	1,2,3,4 and 5 years after procedure

Collaborators and Investigators

• Sponsor: Guillermo Galeote; MD, PhD
• Investigators: Principal Investigator: Guillermo Galeote, PhD, MD, La Paz University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2019
• Primary Completion (Anticipated): December 27, 2022
• Study Completion (Anticipated): December 4, 2023

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Chronic kidney disease; Intravascular ultrasound; Rotational atherectomy; Severely calcified coronary lesion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Coronary Disease; Coronary Artery Disease; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 00001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes