Coronary Artery DiseaseCRATERNCT05353946
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
A study testing Percutaneous coronary intervention (PCI) in people with Coronary Artery Disease and Chronic Renal Failure, run by Guillermo Galeote; MD, PhD at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease, Chronic Renal Failure
- What is being tested?
- Percutaneous coronary intervention (PCI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2019to 4 Dec 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
La Paz University Hospital
Madrid, 28046
Guillermo Galeote, PhD, MD, +34609024315, ggaleote1@gmail.com
Artemio García-Escobar, MD, +34608936547, dr_garciaescobar@hotmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Chronic Renal Failure
- Being tested
- Percutaneous coronary intervention (PCI)
- Keywords
- Severely calcified coronary lesion, Rotational atherectomy, Chronic kidney disease, Intravascular ultrasound, Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Device
Optimal stent expansion by IVUS-guided PCI.
| Study group | Role | What they receive |
|---|---|---|
| Elective Rotational Atherectomy | Active comparator | 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. Receives: Device: Percutaneous coronary intervention (PCI) |
| Bailout Rotational Atherectomy | Active comparator | 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. Receives: Device: Percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural and 30 days after the procedure
Secondary outcomes (8)
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
During follow-up 5 years.
Measured: Follow-up 5 years.
Contrast-induced nephropathy
Contrast-induced nephropathy 48 hours after the procedure.
Measured: 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
Measured: 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.
Measured: Periprocedural
Procedure and fluoroscopy times
Measured in minutes
Measured: 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
Measured: Periprocedural
In-hospital complications
Target lesion revascularization, target vessel revascularization, non-target vessel revascularization, stent thrombosis, vascular complications, and death
Measured: during hospitalization stay until discharge
Major cardiovascular events
Death, myocardial infarction, target lesion revascularization, target vessel revascularization, and non-target vessel revascularization
Measured: 1,2,3,4 and 5 years after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start2 Feb 2019
- Primary completion27 Dec 2022 (estimated)
- Study completion4 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guillermo Galeote; MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guillermo Galeote; MD, PhD, Hospital Universitario La Paz
- Investigators
- Guillermo Galeote, PhD, MD, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353946
- Sponsor's protocol ID
- 00001
- Acronym
- CRATER
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Galeote G, Zubiaur J, Jurado-Roman A, Fernandez-Portales J, Romani S, Salinas P, Garcia-Tejada J, Subinas A, Rodriguez M, Palazuelos-Molinero J, Flores X, Lopez M, Planas A, Arroyo E, Bastos G, Vera-Vera S, Jimenez-Valero S, Rivero Santana B, Tebar D, Gonzalvez A, Moreno R. Coronary Rotational Atherectomy Elective Versus Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure (CRATER) Trial. Catheter Cardiovasc Interv. 2025 Sep;106(3):1702-1712. doi: 10.1002/ccd.31730. Epub 2025 Jul 2.
PubMed 40600268
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRATER Trial: Coronary Rotational Atherectomy Elective vs. Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT05353946
- Acronym / sponsor ID
- CRATER / 00001
- Conditions
- Coronary Artery Disease, Chronic Renal Failure
- Keywords
- Severely calcified coronary lesion, Rotational atherectomy, Chronic kidney disease, Intravascular ultrasound, Percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Guillermo Galeote; MD, PhDUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 27 Dec 2022 (estimated)
- Study completion
- 4 Dec 2023 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective Rotational Atherectomy | Active comparator | Device: Percutaneous coronary intervention (PCI)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. |
| Bailout Rotational Atherectomy | Active comparator | Device: Percutaneous coronary intervention (PCI)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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary intervention (PCI)Optimal stent expansion by IVUS-guided PCI. | Device | Bailout Rotational Atherectomy, Elective Rotational Atherectomy |
Primary outcome
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
Time frame: 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.
8 secondary outcomes
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)
Time frame: Follow-up 5 years.
Contrast-induced nephropathy
Time frame: 48 hours after the procedure.
Stent placement success
Time frame: Periprocedural
The amount of angioplasty balloons used in each group before stent deployment.
Time frame: Periprocedural
Procedure and fluoroscopy times
Time frame: Periprocedural
Periprocedural complications
Time frame: Periprocedural
In-hospital complications
Time frame: during hospitalization stay until discharge
Major cardiovascular events
Time frame: 1,2,3,4 and 5 years after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 40600268Galeote G, Zubiaur J, Jurado-Roman A, Fernandez-Portales J, Romani S, Salinas P, Garcia-Tejada J, Subinas A, Rodriguez M, Palazuelos-Molinero J, Flores X, Lopez M, Planas A, Arroyo E, Bastos G, Vera-Vera S, Jimenez-Valero S, Rivero Santana B, Tebar D, Gonzalvez A, Moreno R. Coronary Rotational Atherectomy Elective Versus Bailout in Patients With Severely Calcified Lesions and Chronic Renal Failure (CRATER) Trial. Catheter Cardiovasc Interv. 2025 Sep;106(3):1702-1712. doi: 10.1002/ccd.31730. Epub 2025 Jul 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Galeote, PhD, MD principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention (PCI) in people with Coronary Artery Disease and Chronic Renal Failure, run by Guillermo Galeote; MD, PhD at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Galeote, PhD, MD (+34609024315, ggaleote1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout) (time frame: Periprocedural and 30 days after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022; AzTrials last refreshed its copy on 26 Oct 2026.