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

Launched by SPANISH SOCIETY OF CARDIOLOGY · Dec 12, 2024

Keywords

ClinConnect Summary

The ORBIT-SHOCK trial is a research study that aims to compare two different methods for treating calcified blockages in the coronary arteries, which can cause serious heart problems. The two techniques being studied are called orbital atherectomy (OA) and intravascular lithotripsy (IVL). Both methods help prepare the artery for a procedure called percutaneous coronary intervention (PCI), where doctors open up blocked blood vessels to improve blood flow to the heart. Patients who have been diagnosed with coronary artery disease and have specific types of calcified blockages may be eligible to participate in this trial.

To qualify for the study, participants must be at least 18 years old and have certain heart conditions, including chronic or acute coronary syndrome. They should also have blockages that can be treated with PCI and meet specific size requirements for their blood vessels. If you join the trial, you'll be randomly assigned to receive either OA or IVL, and the researchers will monitor your health and any side effects to see which method works better. The trial is not yet recruiting participants, but it's an important step in finding more effective treatments for heart disease.

Gender

ALL

Eligibility criteria

• 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.