Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
NCT ID: NCT06736665
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2025-03-31
2026-12-31
Brief Summary
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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
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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.
Patients will be monitored for 12 months after the procedure to assess the incidence of adverse events during follow-up.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Orbital atherectomy
The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter.
Orbital atherectomy
The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter.
Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure.
These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment.
Percutaneous coronary intervention with stent implantation
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.
Intravascular lithotripsy
The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses.
Intravascular lithotripsy
The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses.
Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure.
These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment.
Percutaneous coronary intervention with stent implantation
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.
Interventions
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Orbital atherectomy
The Diamondback-360 (OAS) (Abbott) device is used to perform this technique, consisting of a bidirectional, diamond-coated orbital crown that utilizes a combination of centrifugal force (creating elliptical orbits) and surface abrasion to modify the calcified plaque and increase distensibility. Additionally, the pulsatile impact of the crown at high speed can create microfractures in deep calcium. As a result, a single 1.25 mm crown can treat vessels ranging from 2.5 to 4 mm in diameter.
Intravascular lithotripsy
The Shockwave Medical Intravascular Lithotripsy System (Shockwave Medical) is a balloon that emits pulsatile sonic waves capable of fracturing intracoronary calcium. This therapy is administered by advancing a catheter and inflating the balloon at low pressure to deliver sonic pulses.
Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT) is an intravascular imaging modality that uses near-infrared light to provide high-definition, cross-sectional and three-dimensional images of the vessel microstructure.
These images provide additional information on the degree and characteristics of coronary artery disease compared to angiography which doesn't delineate the composition of the coronary artery. With automated, highly accurate measurements, OCT can guide stent selection, placement, and deployment.
Percutaneous coronary intervention with stent implantation
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Spanish Society of Cardiology
OTHER
Responsible Party
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Luis Manuel Domínguez Rodríguez
Interventional Cardiologist and Clinical Researcher
Locations
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Hospital Universitario General de Alicante
Alicante, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Countries
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Central Contacts
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Luis Manuel Domínguez-Rodríguez, MD.
Role: CONTACT
Phone: 0034 639 82 56 65
Email: [email protected]
Facility Contacts
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José Valencia-Martín, MD, PhD.
Role: primary
Jeremías Bayón Lorenzo, MD, PhD.
Role: primary
Ángel Sánchez-Recalde, MD, PhD.
Role: primary
Luis Manuel Domínguez-Rodríguez, MD.
Role: backup
Javier Martín-Moreiras, MD, PhD.
Role: primary
Jesús Ignacio Amat-Santos, MD, PhD.
Role: primary
References
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Other Identifiers
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ORBIT-SHOCK
Identifier Type: -
Identifier Source: org_study_id