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

NCT06736665 | Recruiting DMC FDA Device

• 1 other identifier: ORBIT-SHOCK
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Calcified Nodules; Orbital Atherectomy; Intravascular Lithotripsy; Optical Coherence Tomography (OCT); Percutaneous Coronary Intervention (PCI); Chronic Coronary Syndrome; Acute Coronary Syndrome (ACS); Coronary Arterial Disease (CAD); Coronary Calcification

Keywords

Coronary arterial disease; Coronary calcification; Coronary calcified nodules; Orbital atherectomy; Intravascular lithotripsy; Optical Coherence Tomography (OCT); Percutaneous Coronary Intervention (PCI); Chronic Coronary Syndrome; Acute Coronary Syndrome (ACS); ORBIT-SHOCK; ORBIT SHOCK

Outcome Measures

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.

  At the end of percutaneous coronary intervention

Secondary Outcomes (12)

• 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

Study Arms (2)

Orbital atherectomy

ACTIVE COMPARATOR

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.

Device: Orbital atherectomy; Device: Optical Coherence Tomography (OCT); Device: Percutaneous coronary intervention with stent implantation

Intravascular lithotripsy

ACTIVE COMPARATOR

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.

Device: Intravascular lithotripsy; Device: Optical Coherence Tomography (OCT); Device: Percutaneous coronary intervention with stent implantation

Interventions

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.

Orbital atherectomy

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.

Also known as: Shockwave

Intravascular lithotripsy

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.

Intravascular lithotripsy; Orbital atherectomy

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.

Intravascular lithotripsy; Orbital atherectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Society of Cardiology: lead
• Abbott: collaborator

Study Sites (6)

Hospital Universitario General de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47003, Spain

RECRUITING

Hospital Universitario Reina Sofía de Córdoba

Córdoba, Spain

RECRUITING

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MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Tomography, Optical Coherence; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Ángel Sánchez-Recalde, MD, PhD.

CONTACT

0034 676 59 95 32; asrecalde@hotmail.com

Luis Manuel Domínguez-Rodríguez, MD.

CONTACT

0034 639 82 56 65; luis-s-ma@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist and Clinical Researcher

Model Details: Once the presence of a calcified nodular lesion is confirmed and the patient meets the inclusion criteria without any exclusion criteria, the patient will be randomized to one of the two treatment techniques being evaluated in the study (OA vs. IVL) in a 1:1 ratio. A stratified randomization will be implemented based on the type of calcified nodule (eruptive or non-eruptive) to ensure equal proportions of each type between the two treatment groups.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: June 12, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

ES (6)