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

Last updated: April 26, 2026
Sponsor: Spanish Society of Cardiology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Attack (Myocardial Infarction)

Angina

Coronary Artery Disease

Treatment

Intravascular lithotripsy

Percutaneous coronary intervention with stent implantation

Orbital atherectomy

Clinical Study ID

NCT06736665
ORBIT-SHOCK
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged ≥ 18 years.

  2. Atherosclerotic coronary artery disease with calcified nodules identified by OCT ina native vessel, eligible for percutaneous coronary revascularization.

  3. Clinical presentation of chronic coronary syndrome or acute coronary syndromewithout ST elevation*.

  4. Distal vessel reference diameters ≥ 2.5 mm and ≤ 4.0 mm. * Non-culprit lesionseligible for revascularization in a staged procedure following a ST-elevationmyocardial infarction (STEMI) are considered for inclusion.

Exclusion

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 thelesion 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 threemonths before or after angioplasty.

  8. Pregnancy.

  9. Life expectancy of less than one year.

  10. Contraindication for the use of appropriate antiplatelet therapypost-revascularization.

  11. Coronary artery disease with an indication for surgical revascularization.

  12. Advanced chronic kidney disease or anatomical characteristics that contraindicatethe use of optical coherence tomography.

  13. Inability to obtain informed consent.

  14. Allergy to eggs or soy, contraindicating the use of OA.

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Intravascular lithotripsy
Phase:
Study Start date:
June 12, 2025
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Hospital Universitario General de Alicante

    Alicante, Alicante 03010
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo 27003
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid 28034
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, Salamanca 37007
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid 47003
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía de Córdoba

    Córdoba,
    Spain

    Active - Recruiting

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