Two Devices for Treating Calcified Blockages in Heart Arteries
Compares two devices that prepare hard calcium deposits in coronary arteries before stenting, in adults.
Plain-language title generated from the registry record
Registry title: Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
Key facts
- Where
- Alicante, Córdoba, Lugo, Madrid, Salamanca, and Valladolid, SpainSee the 6 sites
Where in Spain
- Hospital Universitario General de AlicanteAlicante, SpainTaking people
- Hospital Universitario Reina Sofia de CórdobaCórdoba, SpainTaking people
- Hospital Universitario Lucus AugustiLugo, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
- Hospital Clínico Universitario de ValladolidValladolid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Spanish Society of Cardiology
- Trial code
- NCT06736665
- Record updated
- 30 April 2026
- Original description
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).Read full original descriptionShow less
Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.
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.
Inclusion: 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.
Exclusion: 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; 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; 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.