Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
NCT ID: NCT05353946
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
124 participants
INTERVENTIONAL
2019-02-02
2023-12-04
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Percutaneous coronary intervention (PCI)
Optimal stent expansion by IVUS-guided PCI.
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.
Percutaneous coronary intervention (PCI)
Optimal stent expansion by IVUS-guided PCI.
Interventions
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Percutaneous coronary intervention (PCI)
Optimal stent expansion by IVUS-guided PCI.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Guillermo Galeote; MD, PhD
OTHER
Responsible Party
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Guillermo Galeote; MD, PhD
Principal Investigator
Principal Investigators
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Guillermo Galeote, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
La Paz University Hospital
Locations
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La Paz University Hospital
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Guillermo Galeote, PhD, MD
Role: primary
Artemio García-Escobar, MD
Role: backup
Other Identifiers
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00001
Identifier Type: -
Identifier Source: org_study_id