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

RecruitingNAAges 18 Years - anyAllSpanish Society of Cardiology
NCT06736665 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 revascular

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📋 Eligibility rules (as published)
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.
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What it tests

  • Orbital atherectomy
  • Intravascular lithotripsy
  • Optical Coherence Tomography (OCT)
  • Percutaneous coronary intervention with stent implantation
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Where

6 sites
Hospital Universitario General de Alicante
Alicante, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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