NCT06736665 Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
| NCT ID | NCT06736665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spanish Society of Cardiology |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-06-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥ 18 years. 2. Atherosclerotic coronary artery disease with calcified nodules identified by OCT in a native vessel, eligible for percutaneous coronary revascularization. 3. Clinical presentation of chronic coronary syndrome or acute coronary syndrome without ST elevation\*. 4. 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: 1. Culprit lesions in acute coronary syndrome with ST elevation. 2. Left main disease. 3. In-stent restenosis lesions. 4. 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. 5. Lesion involving a bifurcation with a secondary branch diameter ≥2 mm. 6. Cardiogenic shock. 7. Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty. 8. Pregnancy. 9. Life expectancy of less than one year. 10. Contraindication for the use of appropriate antiplatelet therapy post-revascularization. 11. Coronary artery disease with an indication for surgical revascularization. 12. Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography. 13. Inability to obtain informed consent. 14. Allergy to eggs or soy, contraindicating the use of OA.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06736665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06736665 currently recruiting?
Yes, NCT06736665 is actively recruiting participants. Contact the research team at asrecalde@hotmail.com for enrollment information.
Where is the NCT06736665 trial being conducted?
This trial is being conducted at Alicante, Spain, Lugo, Spain, Madrid, Spain, Salamanca, Spain and 2 additional locations.
Who is sponsoring the NCT06736665 clinical trial?
NCT06736665 is sponsored by Spanish Society of Cardiology. The trial plans to enroll 50 participants.