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

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05786781

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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 hemoptysis

Condition or Disease	Intervention/Treatment	Phase
Hemoptysis	Device: Transarterial CT angiography	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 2, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The accuracy rate of transarterial CT angiography in the identification of culprit vessel [Intraoperative phase]
The accuracy rate of transarterial CT angiography in the identification of culprit vessel
Total effective dose [Intraoperative phase]
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.
Early hemoptysis recurrence rate [3 months after treatment]
Recurrence rate of hemoptysis within 3 months after treatment

Secondary Outcome Measures

Technical success rate [Intraoperative phase]
Technical success is defined as complete cessation of target blood flow confirmed by DSA
Immediate hemostasis success rate [24 hours after treatment]
Hemostasis rate within 24 hours after treatment
The amount of contrast agent consumed [Intraoperative phase]
The amount of contrast agent consumed during treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China

Sponsors and Collaborators

Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wuhan Union Hospital, China

ClinicalTrials.gov Identifier:

NCT05786781

Other Study ID Numbers:

UHCT22759

First Posted:

Mar 28, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemoptysis

Study Results

No Results Posted as of Mar 28, 2023