On-line 3-dimensional OPTical frequency domain IMaging to optimize bifurcation stenting using UltiMaster stent

JRCT ID: jRCTs042180022

Registered date:20/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: coronary artery disease (CAD) patients undergoing coronary stent implantation.
• Date of first enrollment: 08/06/2017
• Target sample size: 106
• Study type: Interventional
• Intervention(s): Bifurcation PCI optimized by online-3D OFDI during and after procedure

Outcome(s)

• Primary Outcome: Post-procedural percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel
• Secondary Outcome: Not applicable

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 NSTE-ACS
3. Subject is appropriate to be treated by PCI according to the local practice (judgment of operator 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 opinion of operator appropriate to be treated by PCI with a single stent strategy
6. The size of main vessel matches available Ultimaster stent sizes (2.25-4.0 mm in diameter 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

Exclude 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 opinion of operator 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. Others, Patient judged inappropriate by the attending physician

Related Information

• Primary Sponsor: Ozaki Yukio
• Source(s) of Monetary Support: Terumo Corporation
• Secondary ID(s): UMIN000024847 / NCT02972489