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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052190093

Registered date:15/01/2020

OFDI vs. IVUS in ACS

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAcute coronary syndrome
Date of first enrollment14/02/2020
Target sample size158
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)OFDI group: If possible, OFDI imaging will be performed before stent implantation. Stenting will be performed with OFDI guidance according to local standard practice. At the end of the procedure, a final OFDI imaging must be performed. After the final OFDI run, a blinded IVUS imaging (documentation only) shall be performed. IVUS group: If possible, IVUS imaging will be performed before stent implantation. Stenting will be performed with IVUS guidance according to local standard practice. At the end of the procedure, a final IVUS imaging must be performed. After the final IVUS run, a blinded OFDI imaging (documentation only) shall be performed.

Outcome(s)

Primary OutcomeMinimum lumen area by OFDI at 8 months after PCI
Secondary Outcome1) OFDI findings at just after the PCI (minimum stent area, minimum lumen area, thrombus, irregular protrusion, edge dissection, hematoma) 2) OFDI findings at 8 months after the PCI (mean neointima thickness, neointima area, mean lumen area, uncovered struts, malapposed struts)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 85age old
GenderBoth
Include criteria1) Patients aged between 20 and 85 years old 2) Patients (or their legally acceptable representatives) who provided written informed consent 3) Patients with ACS who will undergo drug-eluting stent implantation for a de novo lesion in a native coronary artery 4) The target lesion must have a visually estimated reference vessel diameter of 2.25 mm to 3.50 mm.
Exclude criteria1) Patients with cardiogenic shock 2) Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL) 3) Patients on dialysis 4) Women who are pregnant or potential pregnancy 5) Patients who are currently enrolled or scheduled to be enrolled in other clinical trial which has possibility to influence the endpoints of OPINION-ACS trial.

Related Information

Contact

Public contact
Name Hiromasa Otake
Address 7-5-2 Kusunoki-Cho, Chuo-ku, Kobe Hyogo Japan 650-0017
Telephone +81-78-382-5846
E-mail hotake@med.kobe-u.ac.jp
Affiliation Kobe University Hospital
Scientific contact
Name Hiromasa Otake
Address 7-5-2 Kusunoki-Cho, Chuo-ku, Kobe Hyogo Japan 650-0017
Telephone +81-78-382-5846
E-mail hotake@med.kobe-u.ac.jp
Affiliation Kobe University Hospital