Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules … (NCT06736665) | Clinical Trial Compass
RecruitingNot Applicable
Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
Spain50 participantsStarted 2025-06-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Culprit lesions in acute coronary syndrome with ST elevation.
✕. Left main disease.
✕. 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.
What they're measuring
1
Stent expansion
Timeframe: At the end of percutaneous coronary intervention