Open and Endovascular Surgical Treatment for Artery Injuries

Artery Injury Clinical Trial

Official title:

Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03872323
• Other study ID #: 960HP20190045
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2019
• Source: Jinan Military General Hospital
• Contact: Min Li, M.D.
• Phone: 13953176057
• Email: liminyingxiang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Traumatic injuries of peripheral arteries are often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply, as well as with high mortality. Traditionally, an open surgical approach is suggested for the management of artery injury. With the advancement of endovascular techniques, the traditional open vascular exposure and vessel repair are no longer the only option available. The purpose of this study is to compare the effectiveness, long-term safety and explore the safety and efficacy factors between open and endovascular surgical techniques.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2026
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Injuries in the peripheral arteries; Loss of blood supply to the remote area; High-risk emergency artery reconstruction; Participate in the study voluntarily, accept follow up study. -

Exclusion Criteria:

Bleeding can be easily control; There is contraindications for surgical operation. -

Related Conditions & MeSH terms

• Artery Injury
• Wounds and Injuries

Intervention

Procedure:
• Endovascular treatment
The arteries injuries are repaired by endovascular treatment.
• Open surgery
The arteries injuries are repaired by open surgical operation.

Locations

Country	Name	City	State
China	960 Hospital of PLA	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Jinan Military General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year treatment success rate	Treatment success is defined as restored blood flow without clinical complications.	60 months
Secondary	Technically success rate of surgery		immediately after surgery
Secondary	Surgery-related complications or death		60 months
Secondary	Currence of stenosis of target lesion		60 months
Secondary	Device-related serious adverse events		60 months
Secondary	Target lesion was treated by interventional or surgical therapy once again		60 months