NCT02972489

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

November 14, 2016

Last Update Submit

November 21, 2016

Conditions

Coronary Artery DiseaseBifurcation Lesion

Outcome Measures

Primary Outcomes (1)

  • Percentage of malapposed struts

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

    at time of bifurcation PCI surgery

Secondary Outcomes (10)

  • Incidence of fulfilling optimal recrossing criteria on 3D-OFDI

    at time of bifurcation PCI surgery

  • Incomplete stent apposition (ISA) area (mm²)

    at time of bifurcation PCI surgery

  • Minimum lumen area (mm²)

    at time of bifurcation PCI surgery

  • Mean lumen area (mm²)

    at time of bifurcation PCI surgery

  • Minimum stent area (mm²)

    at time of bifurcation PCI surgery

  • +5 more secondary outcomes

Study Arms (2)

3D OFDI guidance arm

EXPERIMENTAL

Bifurcation percutaneous coronary intervention (PCI) optimized by online-3D OFDI during and after procedure

Device: 3D OFDI guidance arm

Angio guidance arm

ACTIVE COMPARATOR

Bifurcation percutaneous coronary intervention (PCI) guided by angiography

Device: Angio guidance arm

Interventions

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.

3D OFDI guidance arm
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.

Angio guidance arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fujita Health University

Toyoake, Aichi-ken, 470-1192, Japan

Location

Erasmus University Medical Center

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Related Publications (7)

  • 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.

    PMID: 25256198BACKGROUND

  • 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.

    PMID: 23714592BACKGROUND

  • 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.

    PMID: 22581489BACKGROUND

  • 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.

    PMID: 22334321BACKGROUND

  • 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.

    PMID: 24531393BACKGROUND

  • 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.

    PMID: 33272034DERIVED

  • 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.

    PMID: 31289018DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Yoshinobu Onuma

    Fujita Health University/Erasmus University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoshinobu Onuma

CONTACT

(011)+31-10-704-0704yoshinobuonuma@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 23, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 23, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)NL(1)