Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions (OraBil)

April 30, 2026 updated by: Fundación EPIC

Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The risk profile of patients and their comorbidities have worsened and the observed lesions undergoing treatment are increasingly complex. This has promoted the development of new technologies for plaque modification, especially in the context of calcified lesions. These predispose to suboptimal results of the intervention due to an increased risk of malapposition and underexpansion of the stents, the main variables for restenosis and/or thrombosis of the stents. Thus, compared with non-calcified lesions, the increased amount of calcium in the coronary artery leads to a higher incidence of major adverse cardiac events (MACE).

Coronary bifurcation stenting remains complex and is associated with a high risk of stent thrombosis and restenosis even with contemporary techniques, and suboptimal outcomes are frequently observed due to side branch (SL) involvement that increases cardiovascular events.

Our hypothesis is that the use of orbital atherectomy (OA) for coronary revascularization in the presence of calcified bifurcation lesions is feasible and safe compared to the more common technique, favoring the subsequent performance of provisional stenting (PS).

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: JORGE PALAZUELOS, MD, PhD
  • Phone Number: 0034659768506
  • Email: jpalaz@gmail.com

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Recruiting
        • H. G.U. de ALICANTE DR. BALMIS
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain, 08041
        • Recruiting
        • H. de La Santa Creu I Sant Pau
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
      • Fuencarral-El Pardo, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Lugo, Spain, 270003
        • Recruiting
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28003
        • Recruiting
        • Hospital Universitario La Luz
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over 18 years of age and
  • Patients with moderately or severely calcified bifurcation lesions (lateral vessel ≥ 2mm), candidates for PCI with coronary stent implantation, in whom there is the possibility of adequate clinical follow-up at 1 year and
  • Patients agree to participate in the study, by signing the Informed Consent.

Exclusion Criteria:

  • Patients with revascularization of the artery to be treated within 9 months prior to the index procedure.

  • Patients with contraindication for the use of Orbital Atherectomy:

    • Patients in cardiogenic shock.
    • Patients with Thrombotic lesions.
    • Patients with Vascular graft disease.
    • Patients with remain vessel disease.
    • Patients with severe left ventricular dysfunction.
    • Patients allergic to the components of the washing serum (glide).
  • Patients with life expectancy less than one year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Balloon Angioplasty (BA)
Device: Balloon System Treatment
Percutaneous coronary intervention of a calcified bifurcation coronary lesion with Orbital Atherectomy followed by drug eluting stent. Baseline and post dilation OCT will be performed.
Active Comparator: Orbital Atherectomy (OA)
Device: Orbital Atherectomy System Treatment
Percutaneous coronary intervention of a calcified bifurcation coronary lesion with balloon angioplasty followed by drug eluting stent. Selection of balloon type is at operator´s discretion. Baseline and post dilation OCT will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFFICACY: Angiographic criteria success
Time Frame: At the end of PCI (Percutaneous Coronary Intervention)
Percentage of Main vessel and side branch (≥2 mm) patency (final stenosis <20%) without the presence of: residual lesion >70% and TIMI flow < 3 and residual ≥ type C disection
At the end of PCI (Percutaneous Coronary Intervention)
EFFICACY: OCT criteria: Stent expansion
Time Frame: At the end of PCI
Percentage of MLA / mean reference luminal area (mean proximal and distal reference luminal)
At the end of PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAFETY:Major adverse cardiac events (MACE)
Time Frame: 12 months
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
12 months
SAFETY:Major adverse cardiac events (MACE)
Time Frame: 6 months
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
6 months
SAFETY:Major adverse cardiac events (MACE)
Time Frame: 30 days
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
30 days
SAFETY:Major adverse cardiac events (MACE)
Time Frame: At the end of PCI
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
At the end of PCI
EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA) in mm2
Time Frame: At the end of PCI
Cut-off point >5 mm2
At the end of PCI
EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA)
Time Frame: At the end of PCI
Percentage of Cut-off point >90 mm2
At the end of PCI
EFFICACY: Other variables related to stent expansion. Mean stent expansion
Time Frame: At the end of PCI
Percentage of mean stent area (sum of stent area/analyzed stent length)/mean reference lumen area (cut-off point>80%)
At the end of PCI
EFFICACY: Other variables related to stent expansion. Stent expansion using linear model
Time Frame: At the end of PCI
Percentage of stent volume/adaptative reference lumen volume. (cut-off point>65%)
At the end of PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIC44-OraBil

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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