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Coronary Artery DiseasePhase 4NCT02972489

Using 3D Imaging to Optimize Bifurcation Stenting

A Phase 4 study testing 3D OFDI guidance arm and Angio guidance arm in people with Coronary Artery Disease and Bifurcation Lesion, run by Increase Co., Ltd. at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Bifurcation Lesion
What is being tested?
3D OFDI guidance arm and Angio guidance arm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
2 sitesin 2 countries
Study dates
Jan 2017to Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is at least 18 years of age and signed Informed Consent
  • 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)
  • Subject is appropriate to be treated by PCI according to the local practice (operator's judgment or heart team decision)
  • Patients' residence is in the area covered by the hospital
  • 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
  • The size of main vessel matches available Ultimaster stent sizes (<4.0 mm, and 2.0 mm by visual assessment)
  • The size of side branch is >2.0mm in diameter by visual assessment
  • The sidebranch is treatable with a sidebranch fenestration and/or kissing balloon

Who cannot join

  • Pregnancy
  • Patients with ST elevation myocardial infarction
  • Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, sirolimus, contrast material
  • Known thrombocytopenia (platelet count< 100,000/mm3)
  • Cardiogenic Shock
  • Significant comorbidities precluding clinical follow-up (as judged by investigators)
Show all 12Show fewer
  • Major planned surgery that requires discontinuation of dual antiplatelet therapy
  • History of stenting in the target bifurcation lesion
  • Renal insufficiency (GFR/MDRD <45 ml/min), which precludes in operator's opinion contrast injection during repeat OFDI pullback
  • 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
  • Target lesion reference vessel diameter (RVD) < 2.25 and > 4 mm
  • Other: Patient is judged inappropriate by the attending physician

Trial locations and contacts

2 sites in 2 countries.

Yoshinobu Onuma contact

(011)+31-10-704-0704

yoshinobuonuma@gmail.com

2 sites in 2 countries

Japan1 site

  • Fujita Health University

    Toyoake, Aichi-ken, 470-1192

Other trials in Japan

Netherlands1 site

  • Erasmus University Medical Center

    Rotterdam, South Holland, 3015 CE

Other trials in Netherlands

About this study

Official title: On-line 3-dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent: OPTIMUM Study

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.

Read the 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.

Being tested
3D OFDI guidance arm, Angio guidance arm
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D OFDI guidance armDevice

    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.

  • Angio guidance armDevice

    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.

Study groups in NCT02972489
Study groupRoleWhat they receive
3D OFDI guidance armExperimentalBifurcation percutaneous coronary intervention (PCI) optimized by online-3D OFDI during and after procedure
Receives: Device: 3D OFDI guidance arm
Angio guidance armActive comparatorBifurcation percutaneous coronary intervention (PCI) guided by angiography
Receives: Device: Angio guidance arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of malapposed struts

    Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel

    Measured: at time of bifurcation PCI surgery

Secondary outcomes (10)

  1. Incidence of fulfilling optimal recrossing criteria on 3D-OFDI

    Measured as a percentage

    Measured: at time of bifurcation PCI surgery

  2. Incomplete stent apposition (ISA) area (mm²)

    Measured: at time of bifurcation PCI surgery

  3. Minimum lumen area (mm²)

    Measured: at time of bifurcation PCI surgery

  4. Mean lumen area (mm²)

    Measured: at time of bifurcation PCI surgery

  5. Minimum stent area (mm²)

    Measured: at time of bifurcation PCI surgery

  6. Mean stent area (mm²)

    Measured: at time of bifurcation PCI surgery

  7. Mean protrusion area (mm²)

    Measured: at time of bifurcation PCI surgery

  8. Maximum protrusion area (mm²)

    Measured: at time of bifurcation PCI surgery

  9. Minimum flow area (mm²)

    Measured: at time of bifurcation PCI surgery

  10. Mean flow area (mm²)

    Measured: at time of bifurcation PCI surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02972489
Sponsor's protocol ID
OPTI001
Status last verified
Nov 2016
First submitted
14 Nov 2016
Last updated
23 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Lassen JF, Holm NR, Stankovic G, Lefevre T, Chieffo A, Hildick-Smith D, Pan M, Darremont O, Albiero R, Ferenc M, Louvard Y. Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings. EuroIntervention. 2014 Sep;10(5):545-60. doi: 10.4244/EIJV10I5A97.

    PubMed 25256198

  • Foin N, Torii R, Alegria E, Sen S, Petraco R, Nijjer S, Ghione M, Davies JE, Di Mario C. Location of side branch access critically affects results in bifurcation stenting: Insights from bench modeling and computational flow simulation. Int J Cardiol. 2013 Oct 9;168(4):3623-8. doi: 10.1016/j.ijcard.2013.05.036. Epub 2013 May 25.

    PubMed 23714592

  • Alegria-Barrero E, Foin N, Chan PH, Syrseloudis D, Lindsay AC, Dimopolous K, Alonso-Gonzalez R, Viceconte N, De Silva R, Di Mario C. Optical coherence tomography for guidance of distal cell recrossing in bifurcation stenting: choosing the right cell matters. EuroIntervention. 2012 Jun 20;8(2):205-13. doi: 10.4244/EIJV8I2A34.

    PubMed 22581489

  • Okamura T, Onuma Y, Garcia-Garcia HM, Bruining N, Serruys PW. High-speed intracoronary optical frequency domain imaging: implications for three-dimensional reconstruction and quantitative analysis. EuroIntervention. 2012 Feb;7(10):1216-26. doi: 10.4244/EIJV7I10A194.

    PubMed 22334321

  • Okamura T, Onuma Y, Yamada J, Iqbal J, Tateishi H, Nao T, Oda T, Maeda T, Nakamura T, Miura T, Yano M, Serruys PW. 3D optical coherence tomography: new insights into the process of optimal rewiring of side branches during bifurcational stenting. EuroIntervention. 2014 Dec;10(8):907-15. doi: 10.4244/EIJV10I8A157.

    PubMed 24531393

  • Onuma Y, Kogame N, Sotomi Y, Miyazaki Y, Asano T, Takahashi K, Kawashima H, Ono M, Katagiri Y, Kyono H, Nakatani S, Muramatsu T, Sharif F, Ozaki Y, Serruys PW, Okamura T; OPTIMUM Investigators. A Randomized Trial Evaluating Online 3-Dimensional Optical Frequency Domain Imaging-Guided Percutaneous Coronary Intervention in Bifurcation Lesions. Circ Cardiovasc Interv. 2020 Dec;13(12):e009183. doi: 10.1161/CIRCINTERVENTIONS.120.009183. Epub 2020 Dec 4.

    PubMed 33272034

  • Miyazaki Y, Muramatsu T, Asano T, Katagiri Y, Sotomi Y, Nakatani S, Takahashi K, Kogame N, Higuchi Y, Ishikawa M, Kyono H, Yano M, Ozaki Y, Serruys PW, Okamura T, Onuma Y. Online three-dimensional OFDI-guided versus angiography-guided PCI in bifurcation lesions: design and rationale of the randomised OPTIMUM trial. EuroIntervention. 2021 Mar 19;16(16):1333-1341. doi: 10.4244/EIJ-D-18-00902.

    PubMed 31289018

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 3D OFDI guidance arm and Angio guidance arm in people with Coronary Artery Disease and Bifurcation Lesion, run by Increase Co., Ltd. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yoshinobu Onuma ((011)+31-10-704-0704, yoshinobuonuma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of malapposed struts (time frame: at time of bifurcation PCI surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02972489, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.

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Using 3D Imaging to Optimize Bifurcation Stenting | AzTrials