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This is a single-arm, exploratory study to evaluate the value of transarterial CT angiography applying Nexaris Angio-CT in the interventional treatment of massive hemoptysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transarterial CT angiography | Experimental | Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transarterial CT angiography | Device | Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy rate of transarterial CT angiography in the identification of culprit vessel | The accuracy rate of transarterial CT angiography in the identification of culprit vessel, by calculating the matching rate between Angio-CT and selective angiography findings. | Intraoperative phase |
| In-hospital clinical success | either the complete cessation of hemoptysis or a clinically significant reduction in bleeding, defined as ≤ 5 mL/24 hours of blood-tinged sputum or fresh blood during the hospitalization period. | During the postoperative hospitalization period (i.e., the period after bronchial artery embolization until discharge) |
| Early hemoptysis recurrence rate | Recurrence rate of hemoptysis within 3 months after treatment | 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | Technical success is defined as complete cessation of target blood flow confirmed by DSA | Intraoperative phase |
| Radiation exposure | Radiation exposure data were systematically collected from structured radiation dose reports. For Angio-CT scans, radiation exposure was quantified using the volume CT dose index (CTDIvol) and dose-length product (DLP). For digital subtraction angiography (DSA) and fluoroscopy, air kerma (AK) and dose-area product (DAP) were utilized as metrics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | China |
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| Intraoperative phase |
| The amount of contrast agent consumed | The amount of contrast agent consumed during treatment | Intraoperative phase |
| Adverse events | AEs were monitored and classified according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The CTCAE system grades AEs on a 5-point scale, with grade ≥ 3 denoting a serious AE. | Intraoperative phase and during 3 months after treatment |
| ID | Term |
|---|---|
| D006469 | Hemoptysis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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