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

NCT05786781 | Completed

• 1 other identifier: UHCT22759
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemoptysis

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Technical success rate

  Intraoperative phase

• Radiation exposure

  Intraoperative phase

• The amount of contrast agent consumed

  Intraoperative phase

• Adverse events

  Intraoperative phase and during 3 months after treatment

Study Arms (1)

Transarterial CT angiography

EXPERIMENTAL

Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis

Device: Transarterial CT angiography

Interventions

Transarterial CT angiography DEVICE

Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis

Transarterial CT angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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）

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Hemoptysis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 28, 2023
• Study Start: March 28, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)