NCT06736665Recruiting
Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- 12 Jun 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Spanish Society of Cardiology
- Diseases
- Coronary artery disease
- NCT number
- NCT06736665
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 12 Jun 2025 to the primary completion date, Dec 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.
- Contraindication for the use of appropriate antiplatelet therapy post-revascularization.
Other illness
- Culprit lesions in acute coronary syndrome with ST elevation.
- Left main disease.
- Coronary artery disease with an indication for surgical revascularization.
- Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.
- Allergy to eggs or soy, contraindicating the use of OA.
Other
- In-stent restenosis lesions.
- 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.
- Lesion involving a bifurcation with a secondary branch diameter ≥2 mm.
- Cardiogenic shock.
- Pregnancy.
- Life expectancy of less than one year.
- Inability to obtain informed consent.
Who the study is looking for
- Patients aged ≥ 18 years.
- Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization.
- Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation\*.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario General de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital Universitario Reina Sofia de Córdoba Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.