Open and Endovascular Surgical Treatment for Artery Injuries
- Conditions
- Artery Injury
- Interventions
- Procedure: Open surgeryProcedure: Endovascular treatment
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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. -
Bleeding can be easily control; There is contraindications for surgical operation. -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open surgery Open surgery - Endovascular treatment Endovascular treatment -
- 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