Back to results

Using 3D Imaging to Optimize Bifurcation Stenting

Primary Purpose

Coronary Artery Disease, Bifurcation Lesion

Status

Unknown status

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

3D OFDI guidance arm

Angio guidance arm

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Fujita Health University
Erasmus University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D OFDI guidance arm

Angio guidance arm

Arm Description

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

Bifurcation percutaneous coronary intervention (PCI) guided by angiography

Outcomes

Primary Outcome Measures

Percentage of malapposed struts

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

Secondary Outcome Measures

Incidence of fulfilling optimal recrossing criteria on 3D-OFDI

Measured as a percentage

Incomplete stent apposition (ISA) area (mm²)

Minimum lumen area (mm²)

Mean lumen area (mm²)

Minimum stent area (mm²)

Mean stent area (mm²)

Mean protrusion area (mm²)

Maximum protrusion area (mm²)

Minimum flow area (mm²)

Mean flow area (mm²)

Full Information

NCT ID

NCT02972489

First Posted

November 14, 2016

Last Updated

November 21, 2016

Sponsor

Increase Co., Ltd.

Collaborators

Fujita Health University, Erasmus Medical Center, Terumo Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02972489

Brief Title

Using 3D Imaging to Optimize Bifurcation Stenting

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Increase Co., Ltd.

Collaborators

Fujita Health University, Erasmus Medical Center, Terumo Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Bifurcation Lesion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

3D OFDI guidance arm

Arm Type

Experimental

Arm Description

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

Arm Title

Angio guidance arm

Arm Type

Active Comparator

Arm Description

Bifurcation percutaneous coronary intervention (PCI) guided by angiography

Intervention Type

Device

Intervention Name(s)

3D OFDI guidance arm

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Angio guidance arm

Intervention Description

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 Measure Information:

Title

Percentage of malapposed struts

Description

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

Time Frame

at time of bifurcation PCI surgery

Secondary Outcome Measure Information:

Title

Incidence of fulfilling optimal recrossing criteria on 3D-OFDI

Description

Measured as a percentage

Time Frame

at time of bifurcation PCI surgery

Title

Incomplete stent apposition (ISA) area (mm²)

Time Frame

at time of bifurcation PCI surgery

Title

Minimum lumen area (mm²)

Time Frame

at time of bifurcation PCI surgery

Title

Mean lumen area (mm²)

Time Frame

at time of bifurcation PCI surgery

Title

Minimum stent area (mm²)

Time Frame

at time of bifurcation PCI surgery

Title

Mean stent area (mm²)

Time Frame

at time of bifurcation PCI surgery

Title

Mean protrusion area (mm²)

Time Frame

at time of bifurcation PCI surgery

Title

Maximum protrusion area (mm²)

Time Frame

at time of bifurcation PCI surgery

Title

Minimum flow area (mm²)

Time Frame

at time of bifurcation PCI surgery

Title

Mean flow area (mm²)

Time Frame

at time of bifurcation PCI surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yoshinobu Onuma

Phone

(011)+31-10-704-0704

yoshinobuonuma@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoshinobu Onuma

Organizational Affiliation

Fujita Health University/Erasmus University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fujita Health University

City

Toyoake

State/Province

Aichi Prefecture

ZIP/Postal Code

470-1192

Country

Japan

Facility Name

Erasmus University Medical Center

City

Rotterdam

State/Province

South Holland

ZIP/Postal Code

3015 CE

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25256198

Citation

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.

Results Reference

background

PubMed Identifier

23714592

Citation

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.

Results Reference

background

PubMed Identifier

22581489

Citation

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.

Results Reference

background

PubMed Identifier

22334321

Citation

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.

Results Reference

background

PubMed Identifier

24531393

Citation

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.

Results Reference

background

PubMed Identifier

33272034

Citation

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.

Results Reference

derived

PubMed Identifier

31289018

Citation

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.

Results Reference

derived

Learn more about this trial

Using 3D Imaging to Optimize Bifurcation Stenting

We'll reach out to this number within 24 hrs