Comparing orbital atherectomy and intravascular lithotripsy for calcified coronary nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ORBIT-SHOCK is a multicenter, prospective, randomized pilot trial enrolling adults with OCT-identified calcified coronary nodules causing significant stenosis who are eligible for PCI. Participants are randomized 1:1 to lesion preparation with either orbital atherectomy or intravascular lithotripsy before stent implantation. The primary endpoint is adequate stent expansion as measured by optical coherence tomography, with secondary endpoints including procedural success, calcium nodule modification, and clinical events over 12 months. Patients will be followed for 12 months to record adverse events and assess longer-term outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario General de Alicante
  Alicante, Alicante, Spain Recruiting
• Hospital Universitario Lucus Augusti
  Lugo, Lugo, Spain Recruiting
• Hospital Universitario Ramón y Cajal
  Madrid, Madrid, Spain Recruiting
• Hospital Universitario de Salamanca
  Salamanca, Salamanca, Spain Recruiting
• Hospital Clínico Universitario de Valladolid
  Valladolid, Valladolid, Spain Recruiting
• Hospital Universitario Reina Sofía de Córdoba
  Córdoba, Spain Recruiting

Study contacts

• Study coordinator: Ángel Sánchez-Recalde, MD, PhD.
• Email: asrecalde@hotmail.com
• Phone: 0034 676 59 95 32

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.