Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 10
- Primary Endpoint
- Stent expansion
Study Overview
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.
Detailed Description
Coronary calcification in the form of calcified nodules (CN) is systematically associated with worse outcomes due to the difficulty in adequately dilation of the lesion and the inability to properly fracture the calcium nodule before stent implantation.
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 CNs, 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).
Primary endpoint: Compare both techniques in terms of achieving adequate stent expansion, measured by OCT.
Secondary endpoints: Evaluate procedural and strategy success rates, assess their impact on calcium nodule modification, and monitor the incidence of adverse clinical events at 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Cardiogenic shock.
- •Patients requiring cardiac surgery or percutaneous valve intervention within three months before or after angioplasty.
- •Life expectancy of less than one year.
- •Contraindication for the use of appropriate antiplatelet therapy post-revascularization.
- •Coronary artery disease with an indication for surgical revascularization.
- •Advanced chronic kidney disease or anatomical characteristics that contraindicate the use of optical coherence tomography.
- •Inability to obtain informed consent.
- •Allergy to eggs or soy, contraindicating the use of OA.
Outcomes
Primary Outcomes
Stent expansion
Time Frame: At the end of percutaneous coronary intervention
Percentage of stent expansion at the CN site: measured with OCT, defined as the ratio between the minimum stent area at the CN site and the average of the distal and proximal reference areas.
Secondary Outcomes
- Procedural success(At the end of percutaneous coronary intervention)
- Strategy success(At the end of percutaneous coronary intervention)
- Minimum stent area(At the end of percutaneous coronary intervention)
- Minimum stent area at the CN site.(At the end of percutaneous coronary intervention)
- Significant stent malapposition at the CN site(At the end of percutaneous coronary intervention)
- Degree of calcium nodule debulking(At the end of percutaneous coronary intervention)
- Evidence of fracture at the CN site(At the end of percutaneous coronary intervention)
- Degree of stent ellipticity at the CN site(At the end of percutaneous coronary intervention)
- Residual luminal protrusion of the calcium nodule following stent implantation(At the end of percutaneous coronary intervention)
- Target lesion failure (TLF) at 12 months(At 12 months)
- Target lesion revascularization (TLR) at 12 months(At 12 months)
- Major Adverse Cardiovascular Events (MACE) at 12 months(At 12 months)
Investigators
Luis Manuel Domínguez Rodríguez
Interventional Cardiologist and Clinical Researcher
Spanish Society of Cardiology