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| Name | Class |
|---|---|
| Beijing Jingruitianhe Medical Science and Technology Development Co,Ltd | UNKNOWN |
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This prospective, multicenter, single-arm study aims to evaluate the safety, operability and practicability of the novel hybrid intravascular imaging system/catheter during the percutaneous transluminal coronary intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novasight IVUS/OCT | Experimental | A coronary segment with stent will be imaged by the Novasight IVUS/OCT catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular imaging | Diagnostic Test | Use of imaging catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clear image length measured by Core lab | The clear image length is transformed from the clear image frame, and the ratio of the clear image can be calculated by Clear image length / Full image length * 100% | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter-related major adverse events | Cardiac death, myocardial infarction, blood-limited dissection | Periprocedure |
| Clear stent length measured by Core lab | Clear stent length is defined as the total stent length visualized within the clear image length. |
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Inclusion Criteria:
Exclusion Criteria:
Angiographic exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muyan Zou | Contact | 0086-15564579827 | zoumuyan@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Chaoyang District | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40049934 | Derived | Jin Q, Fu Z, Wang Y, Zeng Y, Zhang X, Ye Y, Tang Y, Xu X, Chen Y. A Multicenter Feasibility and Safety Study of a Novel Hybrid IVUS-OCT Imaging System. JACC Asia. 2025 Mar;5(3 Pt 1):396-400. doi: 10.1016/j.jacasi.2025.01.009. |
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According to the policy of the Human Genetic Resource Administration of China, the data is limited and it could not be shared currently.
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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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| During the procedure |
| Device Success | Successfully deliver the catheter to the target lesion and withdrawal without fracture | During the procedure |
| Technical Success | Successfully imaging | During the procedure |
| Image quality evaluated by operator | Objective and subjective assessment of image quality. | During the procedure |
| System reliability evaluated by operator | Objective and subjective assessment of system reliability. | During the procedure |
| Catheter operability evaluated by operator | Objective and subjective assessment of catheter operability. | During the procedure |
| Beijing Tiantan Hospital, Capital Medical University | Not yet recruiting | Beijing | Fengtai District | 100050 | China |
| Chinese PLA General Hospital | Recruiting | Beijing | Haidian District | 100039 | China |
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| Peking University Third Hospital | Recruiting | Beijing | Haidian District | China |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |