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NCT Number: NCT05353946

Coronary Rotational Atherectomy Elective vs. Bailout in 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chronic Disease Chronic Renal Failure Coronary Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention (PCI)

Device

Optimal stent expansion by IVUS-guided PCI.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The healthcare cost analysis between elective atherectomy and conventional atherectomy (bailout)

    Time frame: Follow-up 5 years.

    During follow-up 5 years.

  2. Contrast-induced nephropathy

    Time frame: 48 hours after the procedure.

    Contrast-induced nephropathy 48 hours after the procedure.

  3. Stent placement success

    Time frame: Periprocedural

    Defined as expansion with <20% residual stenosis assessed by intravascular ultrasound and TIMI 3 flow without crossover or stent failure

  4. The amount of angioplasty balloons used in each group before stent deployment.

    Time frame: Periprocedural

    Number of semi-compliant and non-compliant balloons used during procedure deployment.

  5. Procedure and fluoroscopy times

    Time frame: Periprocedural

    Measured in minutes

  6. Periprocedural complications

    Time frame: Periprocedural

    Coronary dissection (NHLBI classification system), coronary perforation (Ellis classification system), no-reflow phenomenon (defined as less than TIMI 3 flow), and side branch occlusion

  7. In-hospital complications

    Time frame: during hospitalization stay until discharge

    Target lesion revascularization, target vessel revascularization, non-target vessel revascularization, stent thrombosis, vascular complications, and death

  8. Major cardiovascular events

    Time frame: 1,2,3,4 and 5 years after procedure

    Death, myocardial infarction, target lesion revascularization, target vessel revascularization, and non-target vessel revascularization

Study contacts

Contact information is provided by the study sponsor or research team.

Artemio García-Escobar, MD

CONTACT

[email protected]

+34608936547

Guillermo Galeote, PhD, MD

CONTACT

[email protected]

+34609024315

Sponsors and collaborators

Lead sponsor

Guillermo Galeote; MD, PhD

Other

Registry information

Official study title

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

Acronym: CRATER

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 29, 2022
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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