Using 3D Imaging to Optimize Bifurcation Stenting

Increase Co., Ltd.

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease; Bifurcation Lesion

Treatments: Device: 3D OFDI guidance arm; Device: Angio guidance arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02972489

OPTI001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

3D OFDI guidance arm

Experimental group

Description:

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

Treatment:

Device: 3D OFDI guidance arm

Angio guidance arm

Active Comparator group

Description:

Bifurcation percutaneous coronary intervention (PCI) guided by angiography

Treatment:

Device: Angio guidance arm