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

NCT05353946 | Recruiting FDA Device

• 1 other identifier: 00001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Chronic Renal Failure

Keywords

Severely calcified coronary lesion; Rotational atherectomy; Chronic kidney disease; Intravascular ultrasound; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  Follow-up 5 years.

• Contrast-induced nephropathy

  48 hours after the procedure.

• Stent placement success

  Periprocedural

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

  Periprocedural

• Procedure and fluoroscopy times

  Periprocedural

Study Arms (2)

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.

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.

Device: Percutaneous coronary intervention (PCI)

Interventions

Percutaneous coronary intervention (PCI) DEVICE

Optimal stent expansion by IVUS-guided PCI.

Bailout Rotational Atherectomy; Elective Rotational Atherectomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guillermo Galeote; MD, PhD: lead

Study Sites (1)

La Paz University Hospital

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

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

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Guillermo Galeote, PhD, MD

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Galeote, PhD, MD

CONTACT

+34609024315; ggaleote1@gmail.com

Artemio García-Escobar, MD

CONTACT

+34608936547; dr_garciaescobar@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 29, 2022
• Study Start: February 2, 2019
• Primary Completion: December 27, 2022
• Study Completion: December 4, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

ES (1)