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

Coronary Artery Disease Clinical Trial

— CRATER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353946
• Other study ID #: 00001
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2019
• Est. completion date: December 4, 2023

Study information

• Verified date: April 2022
• Source: Hospital Universitario La Paz
• Contact: Guillermo Galeote, PhD, MD
• Phone: +34609024315
• Email: ggaleote1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 4, 2023
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Coronary Artery Disease
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Spain	La Paz University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Guillermo Galeote; MD, PhD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)	During follow-up 5 years.	Follow-up 5 years.
Secondary	Contrast-induced nephropathy	Contrast-induced nephropathy 48 hours after the procedure.	48 hours after the procedure.
Secondary	Stent placement success	Defined as expansion with <20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure	Periprocedural
Secondary	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
Secondary	Procedure and fluoroscopy times	Measured in minutes	Periprocedural
Secondary	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
Secondary	In-hospital complications	Target lesion revascularization, target vessel revascularization, non-target vessel revascularization, stent thrombosis, vascular complications, and death	during hospitalization stay until discharge
Secondary	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