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Completed

NCT Number: NCT05786781

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wuhan, Hubei, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transarterial CT angiography

Device

Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis

Primary outcomes

  1. The accuracy rate of transarterial CT angiography in the identification of culprit vessel

    Time frame: Intraoperative phase

    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.

  2. In-hospital clinical success

    Time frame: During the postoperative hospitalization period (i.e., the period after bronchial artery embolization until discharge)

    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.

  3. Early hemoptysis recurrence rate

    Time frame: 3 months after treatment

    Recurrence rate of hemoptysis within 3 months after treatment

Secondary outcomes

  1. Technical success rate

    Time frame: Intraoperative phase

    Technical success is defined as complete cessation of target blood flow confirmed by DSA

  2. Radiation exposure

    Time frame: Intraoperative phase

    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.

  3. The amount of contrast agent consumed

    Time frame: Intraoperative phase

    The amount of contrast agent consumed during treatment

  4. Adverse events

    Time frame: Intraoperative phase and during 3 months after treatment

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2023
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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