NCT07422688

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
161mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
12 countries

19 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Nov 2025Sep 2039

First Submitted

Initial submission to the registry

September 30, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 23, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2039

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

4.8 years

First QC Date

September 30, 2025

Last Update Submit

June 3, 2026

Conditions

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

Keywords

OCT guided PCIACS undergoing PCI

Outcome Measures

Primary Outcomes (1)

  • Combined endpoint of major adverse cardiac events (MACE)

    Comprising all-cause death, spontaneous myocardial infarction and stroke

    12 months

Secondary Outcomes (17)

  • Combined endpoint of major adverse cardiac events (MACE)

    30 days, 36 months and 60 months

  • Patient-oriented composite (PoCE) MACE endpoint

    30 days, 12 months, 36 months and 60 months

  • All-cause mortality

    30 days, 12 months, 36 months, 60 months and 10 years

  • Cardiac death

    30 days, 12 months, 36 months and 60 months

  • Spontaneous myocardial infarction

    30 days, 12 months, 36 months and 60 months

  • +12 more secondary outcomes

Other Outcomes (7)

  • Contrast volume

    Baseline (index procedure and procedures staged within the same index admission)

  • Fluoroscopy time

    Baseline (index procedure and procedures staged within the same index admission)

  • Length of stents implanted in culprit lesion

    Baseline (index procedure and procedures staged within the same index admission)

  • +4 more other outcomes

Study Arms (2)

Angiographic Guided PCI

ACTIVE COMPARATOR

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

Procedure: Angiographic Guided PCI

OCT Guided PCI

EXPERIMENTAL

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

Procedure: OCT Guided PCI

Interventions

Angiographic Guided PCIPROCEDURE

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

Angiographic Guided PCI
OCT Guided PCIPROCEDURE

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

OCT Guided PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NSTEMI, STEMI
  • Symptom duration \<12h for STEMI and \<48h for NSTEMI
  • Age ≥ 18yrs
  • Ability to provide written informed consent
  • 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

You may not qualify if:

  • 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
  • Study lesion involving the Left main coronary artery
  • Study lesion involving a true bifurcation lesion with a SB \>2.5mm
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Leuven University Hospital

Leuven, 3000, Belgium

Location

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Aarhus University Hospital Skejby

Aarhus N, 8200, Denmark

Location

Rigshospitalet

København Ø, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Zealand University Hospital, Roskilde Sygehus

Roskilde, 4000, Denmark

Location

North-Estonia Medical Centre

Tallinn, 13419, Estonia

Location

North Karelia Central Hospital

Joensuu, Finland

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Turin Nord Emergency Hospital

Turin, 10154, Italy

Location

Latvia Centre of Cardiology

Riga, LV-1002, Latvia

Location

Radboud University Medicine Center

Nijmegen, Netherlands

Location

Hospital of Southern Norway, Arendal

Arendal, 4604, Norway

Location

Akerhus University Hospital - AHUS

Lørenskog, 1478, Norway

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, 14157, Sweden

Location

University Hospital of Zürich

Zurich, 8091, Switzerland

Location

Royal Bournemouth Hospital

Bournemouth, BH77DW, United Kingdom

Location

MeSH Terms

Conditions

Myocardial IschemiaAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Evald H Christiansen, Prof.MD.PhD

    Aarhus University Hospital

    STUDY CHAIR

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
Prof., MD, PhD

Study Record Dates

First Submitted

September 30, 2025

First Posted

February 20, 2026

Study Start

November 23, 2025

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2039

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Limited and pseudo-anonymized data will be transferred to studies investigating the effect of OCT treatment across other studies, so-called meta-analyses. These meta-analyses will be carried out with Rigshospitalet (Copenhagen, Denmark) and the Cardiovascular Research Foundation (New York, USA). Full anonymization means that the information cannot be linked to individuals. The studies to which data are transferred comply with the General Data Protection Regulation and the Danish Data Protection Act. Data from this study will also be transferred to a project at Aarhus University investigating prognosis across patient groups treated with OCT.

Locations

FI(1)DE(2)DK(5)LA(1)IT(1)SE(2)BE(1)ES(1)NL(1)NO(2)CH(1)GB(1)