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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000010580 | Registry Identifier | UMIN Clinical Trials Registry |
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| Name | Class |
|---|---|
| Wakayama Medical University | OTHER |
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The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.
Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment.
The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.
We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided PCI arm.
Patients will then have a follow-up contact at the time of hospital discharge, 8 month and 12 month after PCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFDI-guided PCI | Experimental |
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| IVUS-guided PCI | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFDI | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure (TVF) | The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR) | 12 months after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | 12 months after PCI | |
| Myocardial Infarction (MI) | 12 months after PCI | |
| Clinically-driven Target lesion revascularization (TLR) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with Acute Myocardial Infarction (AMI) within 3 months
Patients with cardiogenic shock
Patients with chronic heart failure
Patients with renal failure (eGFR <= 30 ml/min/1.73 m2 or Serum creatinine level >=1.5mg/dL)
Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial.
Patients planned use of bare metal stent
Patients with 3-vessel diseases
Planned surgery within 1 year
Patient on dialysis
Target lesion such as:
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| Name | Affiliation | Role |
|---|---|---|
| Takashi Akasaka, MD, PhD | Wakayama Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wakayama Medical University | Wakayama | Wakayama | 641-8510 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29121226 | Derived | Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| IVUS | Device |
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| 12 months after PCI |
| MACE (composite of cardiac death, MI, TLR) | 12 months after PCI |
| Target Vessel Revascularization (TVR) | 12 months after PCI |
| Stroke | 12 months after PCI |
| Stent thrombosis | 12 months after PCI |
| Binary restenosis | 12 months after PCI |
| Renal dysfunction | 8 months after PCI |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |