OFDI vs. IVUS in ACS

Phase 3

• Conditions: Acute coronary syndrome

• Registration Number: JPRN-jRCTs052190093
• Lead Sponsor: Otake Hiromasa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-15
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 158

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Minimum lumen area by OFDI at 8 months after PCI

Secondary Outcome Measures

Name	Time	Method
1) OFDI findings at just after the PCI (minimum stent area, minimum lumen area, thrombus, irregular protrusion, edge dissection, hematoma)<br>2) OFDI findings at 8 months after the PCI (mean neointima thickness, neointima area, mean lumen area, uncovered struts, malapposed struts)