An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Hemoptysis

Study Overview
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Brief Summary
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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 hemoptysis

Official Title
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An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Hemoptysis

Conditions
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Hemoptysis

Intervention / Treatment
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* Device: Transarterial CT angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with massive hemoptysis（defined as more than 100mL per session or more than 300mL/day）or patients with recurrent mild to moderate hemoptysis and failed conservative treatment history Exclusion Criteria: Pregnancy Patients with a previous history of bronchial artery embolization Uncorrectable severe infection, coagulation dysfunction, organ failure or cachexia, severe contrast agent allergy, and other interventional treatment contraindications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transarterial CT angiography<br>Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis | Device: Transarterial CT angiography<br>* Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | Intraoperative phase | 
| Total effective dose | The total effective dose is the sum of the effective dose delivered by CT, fluoroscopy and DSA. The effective dose delivered by CT was determined using the dose length product (expressed as mGy*cm) and subsequently converted to the ED using a suitable conversion factor (0.014 mSv mGy-1 cm-1). The effective dose delivered by fluoroscopy and DSA was determined using the dose area product (expressed as mGy*cm2) and subsequently converted to the ED using a suitable conversion factor (0.12 mSv Gy-1cm-2). The dose length product and the dose area product were acquired on radiation dose structured reports. | Intraoperative phase | 
| Early hemoptysis recurrence rate | Recurrence rate of hemoptysis within 3 months after treatment | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | Technical success is defined as complete cessation of target blood flow confirmed by DSA | Intraoperative phase | 
| Immediate hemostasis success rate | Hemostasis rate within 24 hours after treatment | 24 hours after treatment | 
| The amount of contrast agent consumed | The amount of contrast agent consumed during treatment | Intraoperative phase |