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NCT07422688Enrolling by invitation

Optical Coherence Tomography in Acute Vessel Evaluation

Optical Coherence Tomography in Acute Vessel Evaluation (OCTAVE)

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
3000 (estimated)
First submitted
30 Sept 2025
Start date
23 Nov 2025
Primary completion date
1 Sept 2030
Lead sponsor
Aarhus University Hospital Skejby
NCT number
NCT07422688

What you commit to

  • Study type: Interventional
  • Planned participants: 3000
  • From 23 Nov 2025 to the primary completion date, 1 Sept 2030
  • 28 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known or anticipated compliance problems with medical therapy
    • Angiographic exclusion criteria

Other illness

  • Known severe heart failure with NYHA class equal or above III
  • Active bleeding or coagulopathy
  • Relevant allergies (contrast media, aspirin, clopidogrel, ticagrelor, everolimus)

Lab values

  • Known ejection fraction \<30% before the admission
  • Known renal failure with GFR \<30 ml/min/1.73 m2

Other

  • 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
  • Suspected inability to lie flat for the duration of the PCI procedure
  • Inability to comply with the planned follow-up program
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ziekenhuis Oost-Limburg
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GenkBelgiumUnknown status
Jessa Hospital
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HasseltBelgiumUnknown status
Leuven University hospital
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LeuvenBelgiumUnknown status
University Hospital of Zurich
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ZurichSwitzerlandUnknown status
Aalborg University Hospital
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AalborgDenmarkUnknown status
Aarhus University Hospital Skejby
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Aarhus NDenmarkUnknown status
Rigshospitalet
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København ØDenmarkUnknown status
Odense University Hospital
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OdenseDenmarkUnknown status
Zealand University Hospital, Roskilde Sygehus
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RoskildeDenmarkUnknown status
North Estonia Medical Centre
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TallinnEstoniaUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
North Karelia Central Hospital
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JoensuuFinlandUnknown status
Kuopio University Hospital
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KuopioFinlandUnknown status
Royal Bournemouth Hospital
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BournemouthUnited KingdomUnknown status
St James's Hospital
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LeedsUnited KingdomUnknown status
St. Bartholomew's Hospital
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LondonUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
John Radcliffe Hospital - Oxford Heart Centre
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OxfordUnited KingdomUnknown status
Turin Nord Emergency Hospital
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TurinItalyUnknown status
Latvia Centre of Cardiology
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RigaLatviaUnknown status
Hospital of Southern Norway, Arendal
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ArendalNorwayUnknown status
Akerhus University Hospital - AHUS
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LørenskogNorwayUnknown status
Auckland City Hospital
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AucklandNew ZealandUnknown status
Danderyds sjukhus
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DanderydSwedenUnknown status
Sahlgrenska University Hospital
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GothenburgSwedenUnknown status
Sunderby Sjukhus
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LuleåSwedenUnknown status
Karolinska Universitetssjukhuset
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StockholmSwedenUnknown status
Akademiske Sjukhuset
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UppsalaSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.