Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study
Condition: Ischaemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional

Summary: 
      Intracoronary optical coherence tomography (OCT) imaging allows for high-resolution
      characterization of coronary lesions. Difficulties in matching cross-sectional OCT-images
      with angiographic lesion localization, however, may limit its clinical utilization. The
      investigators sought to prospectively assess the impact of a novel system of real-time
      OCT-coregistration with angiography (ACR) compared to OCT alone and to the clinical standard
      proceeding (angiographic guided-PCI) all used for coronary lesion evaluation before
      percutaneous coronary interventions (PCI). The investigators hypothesize that the use of ACR
      will lead to less incidence of insufficient covered coronary lesions (geographical mismatch)
      and/or a less rate of edge dissections after PCI (combined primary study endpoint)
    

Detailed description: 
      In this randomized blinded pilot-study the effect of pre-PCI planning by
      angiographic-co-registered OCT (ACR) compared to OCT or angiographic evaluation alone with
      respect to the entire result after PCI will be investigated. A special focus (primary
      endpoint) will be on the incidence of geographical mismatch (GM) and/or major edge
      dissections. Eligible patients will be randomized in three groups.

      Group 1 Pre-PCI-OCT: Patients underwent OCT-imaging before PCI. Lesion assessment, selection
      of PCI landing zone as well as stent selection will be performed by investigators based on
      OCT findings.

      Group 2: Pre-PCI-ACR: Patients underwent ACR-imaging before PCI. Lesion assessment, selection
      of PCI landing zone as well as stent selection will be performed by investigators based on
      ACR-findings.

      Group 3:OCT-Blinded/Angiographic guided PCI: Lesion assessment, selection of PCI landing zone
      as well as stent selection will be performed by investigators only based on angiographic
      lesion evaluation (standard care).

      For outcome analysis all study groups underwent post-PCI-OCT imaging as soon as investigators
      assume angiographic justiciable PCI-results (TIMI III, no residual stenosis > 50%; no
      angiographic definable or suspicious edge dissections, angiographic acceptable stent
      expansion without evidence for malapposition). OCT imaging analysis will be performed within
      a OCT core-lab by two investigators blinded for the randomization group.
    

Intervention name(s): Angio-PCI; OCT-PCI; ACR-PCI
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): PCI only with angiography and without OCT findings; PCI with OCT-measurements but no transfer of landingzone-markers to angiography; PCI with OCT-measurements and transfer of landingzone-markers to angiography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCT; Co-Registration; Stent; PCI; Geographical mismatch; Edge Dissection