Open and Endovascular Surgical Treatment for Artery Injuries

Not Applicable

Recruiting

• Conditions: Artery Injury

• Registration Number: NCT03872323
• Lead Sponsor: Jinan Military General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Last Update Submitted: 2019-03-11
• Study First Posted: 2019-03-13
• Last Update Posted: 2019-03-13
• Study Start: 2019-04-01
• Primary Completion: 2024-04-30
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
5-year treatment success rate	60 months	Treatment success is defined as restored blood flow without clinical complications.

Secondary Outcome Measures

Name	Time	Method
Technically success rate of surgery	immediately after surgery
Surgery-related complications or death	60 months
Target lesion was treated by interventional or surgical therapy once again	60 months
Currence of stenosis of target lesion	60 months
Device-related serious adverse events	60 months

Trial Locations

Locations (1)

960 Hospital of PLA; 🇨🇳 Jinan, Shandong, China