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

Официальное название

Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.

Обзор

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.

Подробное описание

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.

Patients will be monitored for 12 months after the procedure to assess the incidence of adverse events during follow-up.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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 deploymen
• Устройство 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.

Первичные конечные точки

• Stent expansion [Срок оценки: At the end of percutaneous coronary intervention]

Вторичные конечные точки (12)

• Procedural success [Срок оценки: At the end of percutaneous coronary intervention]
• Strategy success [Срок оценки: At the end of percutaneous coronary intervention]
• Minimum stent area [Срок оценки: At the end of percutaneous coronary intervention]
• Minimum stent area at the CN site. [Срок оценки: At the end of percutaneous coronary intervention]
• Significant stent malapposition at the CN site [Срок оценки: At the end of percutaneous coronary intervention]
• Degree of calcium nodule debulking [Срок оценки: At the end of percutaneous coronary intervention]
• Evidence of fracture at the CN site [Срок оценки: At the end of percutaneous coronary intervention]
• Degree of stent ellipticity at the CN site [Срок оценки: At the end of percutaneous coronary intervention]
• Residual luminal protrusion of the calcium nodule following stent implantation [Срок оценки: At the end of percutaneous coronary intervention]
• Target lesion failure (TLF) at 12 months [Срок оценки: At 12 months]
• Target lesion revascularization (TLR) at 12 months [Срок оценки: At 12 months]
• Major Adverse Cardiovascular Events (MACE) at 12 months [Срок оценки: At 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Pregnancy.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 6 центров

• Hospital Universitario General de Alicante — Alicante
• Hospital Universitario Lucus Augusti — Lugo
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitario de Salamanca — Salamanca
• Hospital Clínico Universitario de Valladolid — Valladolid
• Hospital Universitario Reina Sofía de Córdoba — Córdoba

Публикации

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Идентификаторы

NCT: NCT06736665 · ORBIT-SHOCK

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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