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NCT Number: NCT06736665

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

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.

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Key information

Conditions

Coronary Arterial Disease (CAD) Acute Coronary Syndrome Acute Coronary Syndrome (ACS) Cardiovascular Diseases Chronic Coronary Syndrome Coronary Calcification Coronary Calcified Nodules Heart Diseases Intravascular Lithotripsy Myocardial Ischemia Optical Coherence Tomography (OCT) Orbital Atherectomy Percutaneous Coronary Intervention (PCI) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario General de Alicante, Alicante, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged ≥ 18 years.
  • Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.
  • Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation*.
  • 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

  • Culprit lesions in acute coronary syndrome with ST elevation.
  • Left main disease.
  • In-stent restenosis lesions.
  • 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.
  • Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.
  • Cardiogenic shock.
  • Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.
  • Pregnancy.
  • Life expectancy of less than one year.
  • Contraindication for the use of appropriate antiplatelet therapy post-revascularization.
  • Coronary artery disease with an indication for surgical revascularization.
  • Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.
  • Inability to obtain informed consent.
  • Allergy to eggs or soy, contraindicating the use of OA.

Treatment and study plan

Orbital atherectomy

Device

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.

Intravascular Lithotripsy

Device

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

Optical coherence tomography (OCT)

Device

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.

Percutaneous coronary intervention with stent implantation

Device

All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Strategy success

    Time frame: At the end of percutaneous coronary intervention

    Defined as procedural success without the need for crossover to an alternative treatment.

  3. Minimum stent area

    Time frame: At the end of percutaneous coronary intervention

    Minimum stent area (MSA)

  4. Minimum stent area at the CN site.

    Time frame: At the end of percutaneous coronary intervention

    Minimum stent area at the CN site.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Study contacts

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

Luis Manuel Domínguez-Rodríguez, MD.

CONTACT

[email protected]

0034 639 82 56 65

Ángel Sánchez-Recalde, MD, PhD.

CONTACT

[email protected]

0034 676 59 95 32

Sponsors and collaborators

Lead sponsor

Spanish Society of Cardiology

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Acronym: ORBIT-SHOCK

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Apr 30, 2026

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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