Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK). (ORBIT-SHOCK)

April 26, 2026 updated by: Luis Manuel Domínguez Rodríguez, Spanish Society of Cardiology

Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.

The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).

Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).

The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).

The aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Coronary calcification in the form of calcified nodules (CN) is systematically associated with worse outcomes due to the difficulty in adequately dilation of the lesion and the inability to properly fracture the calcium nodule before stent implantation.

The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting CNs, identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI).

Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL).

Primary endpoint: Compare both techniques in terms of achieving adequate stent expansion, measured by OCT.

Secondary endpoints: Evaluate procedural and strategy success rates, assess their impact on calcium nodule modification, and monitor the incidence of adverse clinical events at 12 months.

Patients will be monitored for 12 months after the procedure to assess the incidence of adverse events during follow-up.

Study Type

Interventional

Enrollment (Estimated)

50

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: Luis Manuel Domínguez-Rodríguez, MD.
  • Phone Number: 0034 639 82 56 65
  • Email: luis-s-ma@hotmail.com

Study Locations

  • Spain
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofía de Córdoba
        • Contact:
        • Principal Investigator:
          • Manuel Pan, MD, PhD.
    • Alicante
      • Alicante, Alicante, Spain, 03010
        • Recruiting
        • Hospital Universitario General de Alicante
        • Contact:
        • Principal Investigator:
          • José Valencia-Martín, MD, PhD.
    • Lugo
      • Lugo, Lugo, Spain, 27003
        • Recruiting
        • Hospital Universitario Lucus Augusti
        • Contact:
          • Jeremías Bayón Lorenzo, MD, PhD.
          • Phone Number: 0034 657 51 45 08
          • Email: jerebayon@gmail.com
        • Principal Investigator:
          • Jeremías Bayón Lorenzo, MD, PhD.
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ángel Sánchez-Recalde, MD, PhD.
        • Principal Investigator:
          • Luis Manuel Domínguez-Rodríguez, MD.
    • Salamanca
      • Salamanca, Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca
        • Contact:
        • Principal Investigator:
          • Javier Martín-Moreiras, MD, PhD.
    • Valladolid
      • Valladolid, Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
          • Jesús Ignacio Amat-Santos, MD, PhD.
          • Phone Number: 0034 657 92 30 40
          • Email: ijamat@gmail.com
        • Principal Investigator:
          • Jesús Ignacio Amat-Santos, MD, PhD.

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:

  1. Patients aged ≥ 18 years.
  2. Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.
  3. Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation*.
  4. Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. * Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction (STEMI) are considered for inclusion.

Exclusion Criteria:

  1. Culprit lesions in acute coronary syndrome with ST elevation.
  2. Left main disease.
  3. In-stent restenosis lesions.
  4. Critical stenoses where it is not possible to advance the OCT catheter across the lesion after predilation with a balloon of up to 2 mm in diameter.
  5. Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.
  6. Cardiogenic shock.
  7. Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.
  8. Pregnancy.
  9. Life expectancy of less than one year.
  10. Contraindication for the use of appropriate antiplatelet therapy post-revascularization.
  11. Coronary artery disease with an indication for surgical revascularization.
  12. Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.
  13. Inability to obtain informed consent.
  14. Allergy to eggs or soy, contraindicating the use of OA.

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: Orbital atherectomy
The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter.
Device: Orbital atherectomy
The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter.
Device: Optical Coherence Tomography (OCT)

Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure.

These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment.

Device: Percutaneous coronary intervention with stent implantation
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.
Active Comparator: Intravascular lithotripsy
The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses.
Device: Optical Coherence Tomography (OCT)

Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure.

These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment.

Device: Percutaneous coronary intervention with stent implantation
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.
Device: Intravascular lithotripsy
The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses.
Other Names:
  • Shockwave

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent expansion
Time Frame: At the end of percutaneous coronary intervention
Percentage of stent expansion at the CN site: measured with OCT, defined as the ratio between the minimum stent area at the CN site and the average of the distal and proximal reference areas.
At the end of percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: At the end of percutaneous coronary intervention
Achieving a stent expansion of ≥ 80% with TIMI III flow, in the absence of stent loss, coronary perforation, or intraprocedural death.
At the end of percutaneous coronary intervention
Strategy success
Time Frame: At the end of percutaneous coronary intervention
Defined as procedural success without the need for crossover to an alternative treatment.
At the end of percutaneous coronary intervention
Minimum stent area
Time Frame: At the end of percutaneous coronary intervention
Minimum stent area (MSA)
At the end of percutaneous coronary intervention
Minimum stent area at the CN site.
Time Frame: At the end of percutaneous coronary intervention
Minimum stent area at the CN site.
At the end of percutaneous coronary intervention
Significant stent malapposition at the CN site
Time Frame: At the end of percutaneous coronary intervention
Measured using OCT, defined as a stent strut detachment ≥ 0.4 mm from the underlying vessel wall, with a longitudinal extension ≥ 1 mm.
At the end of percutaneous coronary intervention
Degree of calcium nodule debulking
Time Frame: At the end of percutaneous coronary intervention
Reduction in calcium nodule size (mm²), measured after plaque modification and prior to stent implantation.
At the end of percutaneous coronary intervention
Evidence of fracture at the CN site
Time Frame: At the end of percutaneous coronary intervention
Evidence of new disruption or discontinuity observed on OCT after plaque modification and prior to stent implantation.
At the end of percutaneous coronary intervention
Degree of stent ellipticity at the CN site
Time Frame: At the end of percutaneous coronary intervention
Measured using OCT at the end of the procedure, calculated as the ratio of the maximum luminal diameter to the minimum luminal diameter of the stent at the CN site.
At the end of percutaneous coronary intervention
Residual luminal protrusion of the calcium nodule following stent implantation
Time Frame: At the end of percutaneous coronary intervention
Residual luminal protrusion of the calcium nodule following stent implantation, measured by OCT in mm2.
At the end of percutaneous coronary intervention
Target lesion failure (TLF) at 12 months
Time Frame: At 12 months
Composite of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to the target lesion.
At 12 months
Target lesion revascularization (TLR) at 12 months
Time Frame: At 12 months
Repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
At 12 months
Major Adverse Cardiovascular Events (MACE) at 12 months
Time Frame: At 12 months
Defined as a composite of cardiovascular death, non-fatal target lesion myocardial infarction, unplanned target lesion revascularization or stent thrombosis.
At 12 months

Collaborators and Investigators

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

Sponsor

Spanish Society of Cardiology

Collaborators

Abbott

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)

June 12, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORBIT-SHOCK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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