Actively Recruiting
Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
Led by Spanish Society of Cardiology · Updated on 2026-04-30
50
Participants Needed
6
Research Sites
128 weeks
Total Duration
On this page
Sponsors
S
Spanish Society of Cardiology
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- 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 between 2.5 mm and 4.0 mm
- Non-culprit lesions eligible for revascularization in a staged procedure following a ST-elevation myocardial infarction are included
You will not qualify if you...
- Culprit lesions in acute coronary syndrome with ST elevation
- Left main disease
- In-stent restenosis lesions
- Critical stenoses preventing OCT catheter advancement after predilation with a balloon up to 2 mm
- Lesions involving a bifurcation with a secondary branch diameter of 2 mm or greater
- Cardiogenic shock
- Patients needing cardiac surgery or percutaneous valve intervention within three months before or after angioplasty
- Pregnancy
- Life expectancy less than one year
- Contraindication to appropriate antiplatelet therapy post-revascularization
- Coronary artery disease requiring surgical revascularization
- Advanced chronic kidney disease or anatomical issues preventing OCT use
- Inability to give informed consent
- Allergy to eggs or soy contraindicating orbital atherectomy use
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Hospital Universitario General de Alicante
Alicante, Alicante, Spain, 03010
Actively Recruiting
2
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain, 27003
Actively Recruiting
3
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
4
Hospital Universitario de Salamanca
Salamanca, Salamanca, Spain, 37007
Actively Recruiting
5
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain, 47003
Actively Recruiting
6
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Spain
Actively Recruiting
Research Team
Á
Ángel Sánchez-Recalde, MD, PhD.
CONTACT
L
Luis Manuel Domínguez-Rodríguez, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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