Using 3D Imaging to Optimize Bifurcation Stenting

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02972489
• Other study ID #: OPTI001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 14, 2016
• Last updated: November 21, 2016
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Increase Co., Ltd.
• Contact: Yoshinobu Onuma
• Phone: (011)+31-10-704-0704
• Email: yoshinobuonuma[@]gmail.com
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bifurcation Lesion
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Japan	Fujita Health University	Toyoake	Aichi Prefecture
Netherlands	Erasmus University Medical Center	Rotterdam	South Holland

Sponsors (4)

Lead Sponsor	Collaborator
Increase Co., Ltd.	Erasmus Medical Center, Fujita Health University, Terumo Corporation

Countries where clinical trial is conducted

Japan,  Netherlands, 

References & Publications (5)

Alegría-Barrero E, Foin N, Chan PH, Syrseloudis D, Lindsay AC, Dimopolous K, Alonso-González 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. — View 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. — View Citation

Lassen JF, Holm NR, Stankovic G, Lefèvre 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of malapposed struts	Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel	at time of bifurcation PCI surgery	No
Secondary	Incidence of fulfilling optimal recrossing criteria on 3D-OFDI	Measured as a percentage	at time of bifurcation PCI surgery	No
Secondary	Incomplete stent apposition (ISA) area (mm²)		at time of bifurcation PCI surgery	No
Secondary	Minimum lumen area (mm²)		at time of bifurcation PCI surgery	No
Secondary	Mean lumen area (mm²)		at time of bifurcation PCI surgery	No
Secondary	Minimum stent area (mm²)		at time of bifurcation PCI surgery	No
Secondary	Mean stent area (mm²)		at time of bifurcation PCI surgery	No
Secondary	Mean protrusion area (mm²)		at time of bifurcation PCI surgery	No
Secondary	Maximum protrusion area (mm²)		at time of bifurcation PCI surgery	No
Secondary	Minimum flow area (mm²)		at time of bifurcation PCI surgery	No
Secondary	Mean flow area (mm²)		at time of bifurcation PCI surgery	No