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Using 3D Imaging to Optimize Bifurcation Stenting

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ClinicalTrials.gov Identifier: NCT02972489
Recruitment Status : Unknown
Verified November 2016 by Increase Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Sponsor:
Collaborators:
Fujita Health University
Erasmus Medical Center
Terumo Corporation
Information provided by (Responsible Party):
Increase Co., Ltd.

Brief Summary:
The primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation segment.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Bifurcation Lesion Device: 3D OFDI guidance arm Device: Angio guidance arm Phase 4

Detailed Description:

The recently developed optical frequency domain imaging (OFDI) can provide high quality resolution images of the coronary arteries. This new imaging system enhances the understanding of complex coronary lesions and the complex interaction between coronary devices and vessels by assembling/compiling 2-dimensional cross sections.

This 3-dimensional reconstruction with strut segmentation becomes possible on-line in the TERUMO OFDI console with 3-dimensional imaging software, which enables stent enhancement and 3D reconstruction within one minute. This "real time" 3D OFDI will promote the utilisation of 3-dimensional assessment in the treatment of bifurcation lesions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: On-line 3-dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent: OPTIMUM Study
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3D OFDI guidance arm
Bifurcation percutaneous coronary intervention (PCI) optimized by online-3D OFDI during and after procedure
Device: 3D OFDI guidance arm
Subjects randomized to 3D-guidance arm will undergo optical frequency domain imaging (OFDI) assessment in the main vessel after re-wiring into the jailed side branch following stent implantation. If the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm position in 2D and off-line 3D reconstruction. After procedure, OFDI is performed in the main branch.

Active Comparator: Angio guidance arm
Bifurcation percutaneous coronary intervention (PCI) guided by angiography
Device: Angio guidance arm
In angiography-guidance group, wire recrossing into the side branch will be performed using conventional fluoroscopic/angiographic guidance. After finishing the procedure, OFDI is performed in the main branch but the results will be blinded to the operators.




Primary Outcome Measures :
  1. Percentage of malapposed struts [ Time Frame: at time of bifurcation PCI surgery ]
    Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel


Secondary Outcome Measures :
  1. Incidence of fulfilling optimal recrossing criteria on 3D-OFDI [ Time Frame: at time of bifurcation PCI surgery ]
    Measured as a percentage

  2. Incomplete stent apposition (ISA) area (mm²) [ Time Frame: at time of bifurcation PCI surgery ]
  3. Minimum lumen area (mm²) [ Time Frame: at time of bifurcation PCI surgery ]
  4. Mean lumen area (mm²) [ Time Frame: at time of bifurcation PCI surgery ]
  5. Minimum stent area (mm²) [ Time Frame: at time of bifurcation PCI surgery ]
  6. Mean stent area (mm²) [ Time Frame: at time of bifurcation PCI surgery ]
  7. Mean protrusion area (mm²) [ Time Frame: at time of bifurcation PCI surgery ]
  8. Maximum protrusion area (mm²) [ Time Frame: at time of bifurcation PCI surgery ]
  9. Minimum flow area (mm²) [ Time Frame: at time of bifurcation PCI surgery ]
  10. Mean flow area (mm²) [ Time Frame: at time of bifurcation PCI surgery ]


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

Inclusion Criteria:

  1. Patient is at least 18 years of age and signed Informed Consent
  2. Subject has coronary artery disease involving a bifurcation with objective evidence of ischemia including patients with chronic stable angina, silent ischemia and non-ST segment elevation acute coronary syndrome (NSTE-ACS)
  3. Subject is appropriate to be treated by PCI according to the local practice (operator's judgment or heart team decision)
  4. Patients' residence is in the area covered by the hospital
  5. Patients with angiographically significant stenosis (>50 % by visual assessment) in de novo, native, previously unstented bifurcation lesion(s) including left main lesion, which is in operator's opinion appropriate to be treated by PCI with a single stent strategy
  6. The size of main vessel matches available Ultimaster stent sizes (<4.0 mm, and 2.0 mm by visual assessment)
  7. The size of side branch is >2.0mm in diameter by visual assessment
  8. The sidebranch is treatable with a sidebranch fenestration and/or kissing balloon

Exclusion Criteria:

  1. Pregnancy
  2. Patients with ST elevation myocardial infarction
  3. Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, sirolimus, contrast material
  4. Known thrombocytopenia (platelet count< 100,000/mm3)
  5. Cardiogenic Shock
  6. Significant comorbidities precluding clinical follow-up (as judged by investigators)
  7. Major planned surgery that requires discontinuation of dual antiplatelet therapy
  8. History of stenting in the target bifurcation lesion
  9. Renal insufficiency (GFR/MDRD <45 ml/min), which precludes in operator's opinion contrast injection during repeat OFDI pullback
  10. Severely tortuous or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal optical frequency domain imaging (OFDI) or excessive risk of complication to place an OFDI catheter
  11. Target lesion reference vessel diameter (RVD) < 2.25 and > 4 mm
  12. Other: Patient is judged inappropriate by the attending physician

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): NCT02972489


Contacts
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Contact: Yoshinobu Onuma (011)+31-10-704-0704 yoshinobuonuma@gmail.com

Locations
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Japan
Fujita Health University
Toyoake, Aichi Prefecture, Japan, 470-1192
Netherlands
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3015 CE
Sponsors and Collaborators
Increase Co., Ltd.
Fujita Health University
Erasmus Medical Center
Terumo Corporation
Investigators
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Principal Investigator: Yoshinobu Onuma Fujita Health University/Erasmus University Medical Center
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Increase Co., Ltd.
ClinicalTrials.gov Identifier: NCT02972489    
Other Study ID Numbers: OPTI001
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases