NCT07422688

Optical Coherence Tomography in Acute Vessel Evaluation

Optical Coherence Tomography in Acute Vessel Evaluation (OCTAVE)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Angiographic Guided PCI	Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone
PROCEDURE	OCT Guided PCI	Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)

Timeline

• Start date: 2025-11-23
• Primary completion: 2030-09-01
• Completion: 2039-09-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

19 sites across 13 countries: Belgium, Denmark, Estonia, Finland, Germany, Italy, Latvia, Netherlands, Norway, Poland, Sweden, Switzerland, United Kingdom