Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).

Sponsored by Spanish Society of Cardiology

About this trial

Last updated a year ago

Study ID

ORBIT-SHOCK

Status

Not yet recruiting

Type

Interventional

Phase

Phase 4

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started a year ago

What is this trial 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.

What are the participation requirements?

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.