OFDI vs. IVUS in ACS

JRCT ID: jRCTs052190093

Registered date:15/01/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acute coronary syndrome
• Date of first enrollment: 14/02/2020
• Target sample size: 158
• Study type: Interventional

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 Outcome: Minimum lumen area by OFDI at 8 months after PCI

Secondary Outcome

1) 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
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Otake Hiromasa
• Source(s) of Monetary Support: TERUMO CORPORATION