Open and Endovascular Surgical Treatment for Artery Injuries
Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMarch 13, 2019
March 1, 2019
5.1 years
March 11, 2019
March 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
5-year treatment success rate
Treatment success is defined as restored blood flow without clinical complications.
60 months
Secondary Outcomes (5)
Technically success rate of surgery
immediately after surgery
Surgery-related complications or death
60 months
Currence of stenosis of target lesion
60 months
Device-related serious adverse events
60 months
Target lesion was treated by interventional or surgical therapy once again
60 months
Study Arms (2)
Endovascular treatment
ACTIVE COMPARATOROpen surgery
ACTIVE COMPARATORInterventions
The arteries injuries are repaired by endovascular treatment.
Eligibility Criteria
You may qualify if:
- 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. -
You may not qualify if:
- Bleeding can be easily control; There is contraindications for surgical operation. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
960 Hospital of PLA
Jinan, Shandong, 250031, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director
Study Record Dates
First Submitted
March 11, 2019
First Posted
March 13, 2019
Study Start
April 1, 2019
Primary Completion
April 30, 2024
Study Completion
January 1, 2026
Last Updated
March 13, 2019
Record last verified: 2019-03