Using 3D Imaging to Optimize Bifurcation Stenting

Phase 4

• Conditions: Bifurcation Lesion; Coronary Artery Disease
• Interventions: Device: Angio guidance arm; Device: 3D OFDI guidance arm

• Registration Number: NCT02972489
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-21
• Last Update Submitted: 2016-11-21
• Study First Posted: 2016-11-23
• Last Update Posted: 2016-11-23
• Study Start: 2017-01
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angio guidance arm	Angio guidance arm	Bifurcation percutaneous coronary intervention (PCI) guided by angiography
3D OFDI guidance arm	3D OFDI guidance arm	Bifurcation percutaneous coronary intervention (PCI) optimized by online-3D OFDI during and after procedure

Primary Outcome Measures

Name	Time	Method
Percentage of malapposed struts	at time of bifurcation PCI surgery	Percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel

Secondary Outcome Measures

Name	Time	Method
Incomplete stent apposition (ISA) area (mm²)	at time of bifurcation PCI surgery
Minimum lumen area (mm²)	at time of bifurcation PCI surgery
Incidence of fulfilling optimal recrossing criteria on 3D-OFDI	at time of bifurcation PCI surgery	Measured as a percentage
Mean stent area (mm²)	at time of bifurcation PCI surgery
Maximum protrusion 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
Mean protrusion area (mm²)	at time of bifurcation PCI surgery
Minimum flow area (mm²)	at time of bifurcation PCI surgery
Mean flow area (mm²)	at time of bifurcation PCI surgery

Trial Locations

Locations (2)

Fujita Health University; 🇯🇵 Toyoake, Aichi Prefecture, Japan

Erasmus University Medical Center; 🇳🇱 Rotterdam, South Holland, Netherlands