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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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) 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.
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.
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
Stent expansion
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.
Time frame: At the end of percutaneous coronary intervention
Procedural success
Achieving a stent expansion of ≥ 80% with TIMI III flow, in the absence of stent loss, coronary perforation, or intraprocedural death.
Time frame: At the end of percutaneous coronary intervention
Strategy success
Defined as procedural success without the need for crossover to an alternative treatment.
Time frame: At the end of percutaneous coronary intervention
Minimum stent area
Minimum stent area (MSA)
Time frame: At the end of percutaneous coronary intervention
Minimum stent area at the CN site.
Minimum stent area at the CN site.
Time frame: At the end of percutaneous coronary intervention
Significant stent malapposition at the CN site
Measured using OCT, defined as a stent strut detachment ≥ 0.4 mm from the underlying vessel wall, with a longitudinal extension ≥ 1 mm.
Time frame: At the end of percutaneous coronary intervention
Degree of calcium nodule debulking
Reduction in calcium nodule size (mm²), measured after plaque modification and prior to stent implantation.
Time frame: At the end of percutaneous coronary intervention
Evidence of fracture at the CN site
Evidence of new disruption or discontinuity observed on OCT after plaque modification and prior to stent implantation.
Time frame: At the end of percutaneous coronary intervention
Degree of stent ellipticity at the CN site
Measured using OCT at the end of the procedure, calculated as the ratio of the maximum luminal diameter to the minimum luminal diameter of the stent at the CN site.
Time frame: At the end of percutaneous coronary intervention
Residual luminal protrusion of the calcium nodule following stent implantation
Residual luminal protrusion of the calcium nodule following stent implantation, measured by OCT in mm2.
Time frame: At the end of percutaneous coronary intervention
Target lesion failure (TLF) at 12 months
Composite of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to the target lesion.
Time frame: At 12 months
Target lesion revascularization (TLR) at 12 months
Repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Time frame: At 12 months
Major Adverse Cardiovascular Events (MACE) at 12 months
Defined as a composite of cardiovascular death, non-fatal target lesion myocardial infarction, unplanned target lesion revascularization or stent thrombosis.
Time frame: At 12 months
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