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

Phase 4

• Conditions: coronary artery disease, bifurcation lesion

• Registration Number: JPRN-UMIN000024847
• Lead Sponsor: Meditrix Corporation

Brief Summary

a primary endpoint was significantly reduced by about 30% in the OFDI arm, and the metallic carina in the bifurcation was significantly less frequently observed in the OFDI arm . The feasibility of 3D-OFDI was considerably high (98%), and approximately 60% of the patients were able to achieve an optimal wire re-crossing in the first attempt. It was finally achieved in all cases in the OFDI arm. There was no significant difference in radiocontrast volume during the procedure between the two arms.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-01
• Study Completion: 2019-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

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. Others, Patient judged inappropriate by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-procedural percentage of malapposed struts assessed by OFDI in bifurcation segment of main vessel