About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Orbital atherectomy
Device
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
Device
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)
Device
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
Device
All patients will undergo percutaneous coronary intervention with drug-eluting stent implantation after plaque modification using the technique assigned by randomization.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Orbital atherectomyActive comparator 3 interventions

Group B: Intravascular lithotripsyActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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