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OCT cost is high
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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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The primary objective is to determine whether IVUS- (vs. OCT-) guided BVS implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by OCT at 1-year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optical coherent tomography | Experimental | Optical coherent tomography provides more detailed information about the morphology of scaffolds, microstructures and coronary vasculature based on tissue characteristics as compared to conventional IVUS. In spite of angiographic success in BVS placement, further scaffold optimization was required in over a quarter of cases based on OCT findings due to malapposition or scaffold under expansion. |
|
| IntraVascular UltraSound | Active Comparator | Intravascular ultrasound guidance has been associated with improved event-free survival compared with angiographic guidance after DES placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherent tomography | Other | comparative method for BVS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| OCT-measured in-scaffold minimal lumen area | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OCT-measured minimal scaffold area (MSA) | 1 year | |
| OCT-measured mean scaffold expansion | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-Gu | South Korea | |||
| Pusan National University Hospital |
This is not a publicly funded trial.
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| IntraVascular UltraSound |
| Other |
The method of goldstandard for decision stent choice |
|
| Pusan |
| South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D018084 | Ultrasonography, Interventional |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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