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

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

Study Overview

• Status: Completed
• Conditions: Hemoptysis
• Intervention / Treatment: Device: Transarterial CT angiography

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with massive hemoptysis（defined as more than 100mL per session or more than 300mL/day or with acute respiratory failure requiring mechanical ventilation or hemodynamic instability (systolic blood pressure < 90 mmHg), regardless of hemoptysis amount）

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transarterial CT angiography; Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis	Device: Transarterial CT angiography; Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early hemoptysis recurrence rate	Recurrence rate of hemoptysis within 3 months after treatment	3 months after treatment
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)

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
The amount of contrast agent consumed	The amount of contrast agent consumed during treatment	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.	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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Lung Diseases; Signs and Symptoms, Respiratory; Hemoptysis
• Other Study ID Numbers: UHCT22759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No