Clinical trial NCT06736665: Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
Official title: Comparative Efficacy of Orbital Atherectomy and Intravascular Lithotripsy in the Treatment of Calcified Coronary Nodules. The ORBIT-SHOCK Pilot Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Arterial Disease (CAD)
Coronary Calcification
Coronary Calcified Nodules
Orbital Atherectomy
Intravascular Lithotripsy
Optical Coherence Tomography (OCT)
Percutaneous Coronary Intervention (PCI)
Chronic Coronary Syndrome
Acute Coronary Syndrome (ACS)
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
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2024-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stent expansion
timeFrame: At the end of percutaneous coronary intervention
Secondary outcomes:
measure: Procedural success
timeFrame: At the end of percutaneous coronary intervention
measure: Strategy success
timeFrame: At the end of percutaneous coronary intervention
measure: Minimum stent area
timeFrame: At the end of percutaneous coronary intervention
measure: Minimum stent area at the CN site.
timeFrame: At the end of percutaneous coronary intervention
measure: Significant stent malapposition at the CN site
timeFrame: At the end of percutaneous coronary intervention
measure: Degree of calcium nodule debulking
timeFrame: At the end of percutaneous coronary intervention
measure: Evidence of fracture at the CN site
timeFrame: At the end of percutaneous coronary intervention
measure: Degree of stent ellipticity at the CN site
timeFrame: At the end of percutaneous coronary intervention
measure: Residual luminal protrusion of the calcium nodule following stent implantation
timeFrame: At the end of percutaneous coronary intervention
measure: Target lesion failure (TLF) at 12 months
timeFrame: At 12 months
measure: Target lesion revascularization (TLR) at 12 months
timeFrame: At 12 months
measure: Major Adverse Cardiovascular Events (MACE) at 12 months
timeFrame: At 12 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital Universitario General de Alicante
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
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