Condition: Coronary Arterial Disease (CAD) · Coronary Calcification · Coronary Calcified Nodules · Sponsor: Spanish Society of Cardiology
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.
This description comes directly from the study's public registry record.
Ángel Sánchez-Recalde, MD, PhD. · 0034 676 59 95 32 · asrecalde@hotmail.com
Luis Manuel Domínguez-Rodríguez, MD. · 0034 639 82 56 65 · luis-s-ma@hotmail.com
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06736665