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Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study (Integration-II)

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ClinicalTrials.gov Identifier: NCT03646097
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
David Manuel Leistner, Charite University, Berlin, Germany

Brief 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)

Condition or disease Intervention/treatment Phase
Ischaemic Heart Disease Procedure: Angio-PCI Procedure: OCT-PCI Procedure: ACR-PCI Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Real-time Angiographic Co-registered OCT on PCI Results - the Randomized OPTICO-integration II Study
Actual Study Start Date : August 21, 2018
Actual Primary Completion Date : November 29, 2018
Actual Study Completion Date : March 15, 2019

Arm Intervention/treatment
Active Comparator: Blinded-group
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)
Procedure: Angio-PCI
PCI only with angiography and without OCT findings

Active Comparator: OCT-group
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
Procedure: OCT-PCI
PCI with OCT-measurements but no transfer of landingzone-markers to angiography

Experimental: ACR-group
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
Procedure: ACR-PCI
PCI with OCT-measurements and transfer of landingzone-markers to angiography




Primary Outcome Measures :
  1. Incidence of a combined endpoint based on "major edge dissections" (I) AND/OR "geographical mismatch" (II) [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    Analysis of primary endpoint will be assessed by evaluation of proximal and/or distal stent end.

    I) Major edge dissection (MED):

    Major: ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length

    II) Geographical mismatch (GM):

    Untreated plaque with a minimal lumen area <4,5mm2 within 5mm of the reference segment.

    In the postPCI-OCT analysis it is considered as no geographical mismatch, if:

    1. the segment of the lesion is fully covered AND
    2. the stent protrudes maximal 5mm beyond the predetermined landing zone.

    If one of these criteria is not fulfilled, it is considered as geographical mismatch



Secondary Outcome Measures :
  1. Incidence of "major edge dissections" [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    All secondary endpoints of OCT will be assessed by evaluation of proximal and/or distal stent end/segment.

  2. Incidence of "all edge dissections" (major (I) and minor (II)) [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    (I) ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length (II) Any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length

  3. Incidence of "geographical mismatch" [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    see primary endpoint

  4. Stent expansion [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    Defined by the MSA achieved relative to the proximal or distal reference segments.

    The stent length is divided into 2 equal segments (proximal and distal), and the MSA is determined in each segment.

    • Optimal stent expansion: The MSA of the segment is ≥95% of the related reference lumen area
    • Acceptable stent expansion: The MSA of the segment is ≥90% and <95% of the related reference lumen area
    • Unacceptable stent expansion: The MSA of the segment is <90% of the related lumen area

  5. Inacceptable stent expansion [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    see outcome 5

  6. Incidence of "malapposition" [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]

    Incompletely apposed stent struts in at least 5 consecutive OCT-frames (defined as stent struts clearly separated from the vessel wall (lumen border/plaque border) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch).

    Malapposition will be further classified as:

    A) Major: If associated with stent underexpansion (unacceptable stent expansion as defined above) B) Minor: If not associated with significant underexpansion (optimal or acceptable stent expansion as defined above) C) Major and minor


  7. Distance between target and actual lesion coverage [mm] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Defined as the distance between target landing zone and actual landing zone of stent location (proximal and distal end). Therefore, the lesion is divided in two equal halves, so that every segment (proximal and distal) can be analyzed for itself.

  8. Minimal Stent Area (MSA) of target lesion [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Minimal lumen area covered by stent.

  9. Acute Luminal Gain of target lesion [mm] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Gain of Minimal Lumen Diameter (MLD) between prePCI- and postPCI-OCT

  10. Procedure time [min] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Time from reaching the ostium with the guide catheter until pullback of the last one.

  11. Total fluoroscopy time [min] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Total time required for diagnostic angiography and PCI.

  12. Total contrast volume [ml] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Total amount of contrast used for entire intervention (including OCT-pullbacks)

  13. Total stent length [mm] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Addition of each stent length which were used for target lesion

  14. Total number of stents [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Number of stents which were used for target lesion

  15. Maximal stent diameter [mm] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Maximal stent diameter used for target lesion

  16. Complications associated with OCT-examination [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Complications between advancing and pullback of OCT catheter

  17. Complications during hospitalization [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Defined as: new ACS; stent thrombosis of study culprit lesion; new unplaned coronary angiography; new revascularization (PCI/CABG); apoplex/TIA; pacemaker implantation; anaphylactic shock; contrast-induced nephropathy; bleeding; death

  18. DOCE within target lesion [%] [ Time Frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours ]
    Device-oriented composite endpoint within the target lesion. Defined as cardiovascular death, myocardial infarction OR target-lesion revascularization. This composite endpoint will be checked during a follow up after 1 and 3 months.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with indication for coronary angiography for angina (stable or unstable), silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive invasive or non-invasive test must be present), or NSTE-ACS
  • male or non pregnant female patient
  • Signed written informed consent

Exclusion Criteria:

  • Known neoplasia on treatment / without a curative therapeutic approach
  • Presence of one or more co-morbidities which reduces life expectancy to less than 24 months
  • Estimated creatinine clearance <40 ml/min
  • Cardiogenic shock
  • Hemodynamic instability because of arrhythmia
  • Known left ventricular ejection fraction (LVEF) <30%.
  • Therapy requiring psychiatric disorder
  • Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
  • Women who are pregnant or breastfeeding
  • Refusal of study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646097


Locations
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Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12203
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: David M Leistner, PD Dr. med. Managing Senior Physician

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Responsible Party: David Manuel Leistner, PD Dr. med., Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03646097     History of Changes
Other Study ID Numbers: OPTICO-Integration II
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Manuel Leistner, Charite University, Berlin, Germany:
OCT
Co-Registration
Stent
PCI
Geographical mismatch
Edge Dissection

Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases