Comparing orbital atherectomy and intravascular lithotripsy for calcified coronary nodules

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

This pilot trial will see if orbital atherectomy or intravascular lithotripsy better prepares OCT-identified calcified coronary nodules for stent placement in adults with coronary artery disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Spanish Society of Cardiology (Academic / other)
• Locations: 6 sites (Alicante, Alicante and 5 other locations)
• Trial ID: NCT06736665 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with coronary artery disease who have OCT-identified calcified nodules causing significant stenosis in native coronary vessels (2.5–4.0 mm) and are candidates for PCI are ideal for this trial.

Not a fit: Patients with left main disease, in-stent restenosis, bifurcation lesions with a large side branch, lesions too tight to cross with OCT after predilation, cardiogenic shock, or those needing cardiac surgery are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the preferred technique could improve stent expansion, lower complication rates, and reduce the need for repeat procedures in patients with calcified coronary nodules.

How similar studies have performed: Both orbital atherectomy and intravascular lithotripsy have shown effectiveness for treating calcified coronary lesions, but randomized head-to-head data specifically for OCT-identified calcified nodules are limited.

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.

Where this trial is running

Alicante, Alicante and 5 other locations

• 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.

Conditions Coronary Arterial Disease; Coronary Calcification; Coronary Calcified Nodules; Orbital Atherectomy; Intravascular Lithotripsy; Optical Coherence Tomography; Percutaneous Coronary Intervention; Chronic Coronary Syndrome