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

Phase 4

Not yet recruiting

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

• Registration Number: NCT06736665
• Lead Sponsor: Spanish Society of Cardiology

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.

Detailed Description

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-03
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients aged ≥ 18 years.
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

1. Culprit lesions in acute coronary syndrome with ST elevation.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stent expansion	At the end of percutaneous coronary intervention	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.

Secondary Outcome Measures

Name	Time	Method
Procedural success	At the end of percutaneous coronary intervention	Achieving a stent expansion of ≥ 80% with TIMI III flow, in the absence of stent loss, coronary perforation, or intraprocedural death.
Strategy success	At the end of percutaneous coronary intervention	Defined as procedural success without the need for crossover to an alternative treatment.
Minimum stent area	At the end of percutaneous coronary intervention	Minimum stent area (MSA)
Minimum stent area at the CN site.	At the end of percutaneous coronary intervention	Minimum stent area at the CN site.
Significant stent malapposition at the CN site	At the end of percutaneous coronary intervention	Measured using OCT, defined as a stent strut detachment ≥ 0.4 mm from the underlying vessel wall, with a longitudinal extension ≥ 1 mm.
Degree of calcium nodule debulking	At the end of percutaneous coronary intervention	Reduction in calcium nodule size (mm²), measured after plaque modification and prior to stent implantation.
Evidence of fracture at the CN site	At the end of percutaneous coronary intervention	Evidence of new disruption or discontinuity observed on OCT after plaque modification and prior to stent implantation.
Degree of stent ellipticity at the CN site	At the end of percutaneous coronary intervention	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.
Residual luminal protrusion of the calcium nodule following stent implantation	At the end of percutaneous coronary intervention	Residual luminal protrusion of the calcium nodule following stent implantation, measured by OCT in mm2.
Target lesion failure (TLF) at 12 months	At 12 months	Composite of clinically driven target lesion revascularization, myocardial infarction or cardiac death related to the target lesion.
Target lesion revascularization (TLR) at 12 months	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.
Major Adverse Cardiovascular Events (MACE) at 12 months	At 12 months	Defined as a composite of cardiovascular death, non-fatal target lesion myocardial infarction, unplanned target lesion revascularization or stent thrombosis.

Trial Locations

Locations (5)

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