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| Name | Class |
|---|---|
| Second Hospital of Jilin University | OTHER |
| Wuhan Asia Heart Hospital | OTHER |
| Panorama Hengsheng (Beijing) Science and Technology Co., Ltd. | UNKNOWN |
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Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were all recommended for percutaneous coronary intervention (PCI) optimization in the latest guidelines, however, which imaging modality was more suitable as either a diagnostic or guidance tool was still unknown. Recently, a novel, well-designed hybrid imaging system was approved for clinical use, allowing the accurate co-registration of two imaging modalities and immediate, simultaneous image review. For testing each modality in the hybrid imaging system, the investigators conducted this prospective, multicentre, non-inferiority trial. In this study, all participants achieved hybrid IVUS-OCT imaging after stenting, at meanwhile, patients randomly assigned to the IVUS arm were performed control IVUS (OptiCross, Boston Scientific, Natick, MA), and patients randomly assigned to the OCT arm were performed control OCT (C7 Dragonfly Duo, St. Jude Medical, St. Paul, MN). In this study, the investigators evaluated the non-inferiority of standalone IVUS versus control IVUS or standalone OCT versus control OCT in clinical feasibility using clear stent capture rate (CSCR) and safety using perioperative device-related adverse cardiovascular events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular ultrasound | Experimental | Hybrid IVUS-OCT and control IVUS were performed after stenting |
|
| Optical coherence tomography | Experimental | Hybrid IVUS-OCT and control OCT were performed after stenting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular ultrasound | Diagnostic Test | Hybrid IVUS-OCT and control IVUS were performed after stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clear stent capture rate (CSCR) | The CSCR detected was defined as the ratio of the clear stent length to the total stent length | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with clear image length ≥ 24mm | Measured by IVUS, OCT and hybrid IVUS-OCT | During the procedure |
| Detection rate of edge dissection, tissue prolapse and stent malapposition |
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Inclusion Criteria:
Exclusion Criteria:
The lesion-related exclusion criteria:
Patients-level exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Yu, MD, PhD | The Second Affiliated Hospital of Harbin Medical University | Study Chair |
| Bin Liu, MD, PhD | Second Hospital of Jilin University | Principal Investigator |
| Xi Su, MD, PhD | Wuhan Asia Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150086 | China | ||
| Wuhan Asia Heart Hospital |
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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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| ID | Term |
|---|---|
| D018084 | Ultrasonography, Interventional |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Optical coherence tomography | Diagnostic Test | Hybrid IVUS-OCT and control OCT were performed after stenting |
|
Assessed by IVUS, OCT and hybrid IVUS-OCT
| During the procedure |
| Device success rate | Device success is defined as well-manipulated and capable of acquiring intravascular images | During the procedure |
| Adverse procedure-related adverse cardiovascular events | Coronary spasm, acute vessel occlusion, coronary dissection, or thrombosis | Periprocedure |
| Wuhan |
| Hubei |
| 430010 |
| China |
| The Second Hospital of Jilin University | Changchun | Jilin | 150056 | China |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 |
| Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D014054 | Tomography |
| D008919 | Investigative Techniques |