Optical Coherence Tomography in Acute Vessel Evaluation

N/AEnrolling By InvitationNCT07422688

Aarhus University Hospital Skejby3,000 enrolled

Overview

The purpose is to investigate if a strategy of routine OCT based diagnosis and guidance of PCI improves clinical outcomes compared with a standard strategy of guidance by angiography in patients presenting with ACS

Patients presenting with acute coronary syndrome (ACS) have worse short and mid-term prognosis compared with patients revascularized for chronic coronary syndrome. Angiographic assessment of patients with ACS is frequently limited by high ambiguity both in identification of culprit lesions, characterization of non-culprit lesions, and in identification of suboptimal treatment results. Intravascular imaging may improve diagnosis and allow for better treatment optimization during coronary intervention of patients with ACS. The large-scale Chinese IVUS-ACS trial showed a 50% reduction in one-year MACE with IVUS-guided PCI in patients with ACS whereas a number of small studies on routine OCT guiding as well as ACS subgroups in RCTs did not indicate a potential similar benefit with OCT. OCT assessment has several theoretical advantages over IVUS in patients with ACS indicating the need for a well-designed strategy trial on OCT vs angiographic guided PCI. Hypothesis: Routine OCT-guided diagnosis and revascularization yields superior one-year clinical outcome compared with standard angiography-guided diagnosis and revascularization in patients with acute coronary syndrome Methods: Investigator initiated, open label, prospective, 1:1 randomized, multi-center, clinical outcome, superiority trial. Primary Endpoint: Major adverse cardiac events (MACE) comprising all-cause death, spontaneous myocardial infarction and stroke.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

3,000

Conditions

Ischemic Heart Disease Ischemic Coronary Artery Disease ACS (Acute Coronary Syndrome)

Interventions

Angiographic Guided PCIPROCEDURE

Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone

OCT Guided PCIPROCEDURE

Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Clinical inclusion criteria: * NSTEMI, STEMI * Symptom duration \<12h for STEMI and \<48h for NSTEMI * Age ≥ 18yrs * Ability to provide written informed consent Angiographic inclusion criteria: * Angiographic signs of at least one possible culprit lesion. Signs including acute occlusion, partial occlusion, proximal embolus, haziness, high grade stenosis, stent thrombosis * Wire in true distal lumen Exclusion Criteria: Clinical exclusion criteria * Intravascular imaging evaluation of any lesions at index procedure * Cardiogenic shock * Sustained ventricular tachycardia or ventricular fibrillation * Planned CABG * Life expectancy \<1 year * Known severe heart failure with NYHA class equal or above III * Known ejection fraction \<30% before the admission * Known renal failure with GFR \<30 ml/min/1.73 m2 * Active bleeding or coagulopathy * Relevant allergies (contrast media, aspirin, clopidogrel, ticagrelor, everolimus) * Suspected inability to lie flat for the duration of the PCI procedure * Inability to comply with the planned follow-up program * Known or anticipated compliance problems with medical therapy Angiographic exclusion criteria * Study lesion involving the Left main coronary artery * Study lesion involving a true bifurcation lesion with a SB \>2.5mm * Severe tortuosity * Distal embolus * Isolated coronary artery spasm * Suspected spontaneous coronary artery dissection * Chronic total occlusions with treatment indication and no antegrade intra plaque wire pass

Locations (25)

Ziekenhuis Oost-Limburg

Genk, Belgium

Outcomes

Primary Outcomes

Combined endpoint of major adverse cardiac events (MACE)

Comprising all-cause death, spontaneous myocardial infarction and stroke

Time frame: 12 months

Secondary Outcomes

Combined endpoint of major adverse cardiac events (MACE)

Comprising all-cause death, spontaneous myocardial infarction and stroke

Time frame: 30 days, 36 months and 60 months

Patient-oriented composite (PoCE) MACE endpoint

Comprising all cause death, any myocardial infarction, any unplanned revascularization and stroke

Time frame: 30 days, 12 months, 36 months and 60 months

All-cause mortality

All-cause mortality includes death of any cause including cardiac deaths and non-natural causes of deaths

Time frame: 30 days, 12 months, 36 months, 60 months and 10 years

Cardiac death

Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death.

Time frame: 30 days, 12 months, 36 months and 60 months

Spontaneous myocardial infarction

Following 4th universal MI definition

Time frame: 30 days, 12 months, 36 months and 60 months

Any ischemia-driven revascularization

Data from ClinicalTrials.gov

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