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Open and Endovascular Surgical Treatment for Artery Injuries

Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03872323
Enrollment
100
Registered
2019-03-13
Start date
2019-04-01
Completion date
2026-01-01
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artery Injury

Keywords

Artery Injury, Surgery, Endovascular Repair, Peripheral Arteries

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.

Interventions

PROCEDUREEndovascular treatment

The arteries injuries are repaired by endovascular treatment.

PROCEDUREOpen surgery

The arteries injuries are repaired by open surgical operation.

Sponsors

Jinan Military General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frameDescription
5-year treatment success rate60 monthsTreatment success is defined as restored blood flow without clinical complications.

Secondary

MeasureTime frame
Technically success rate of surgeryimmediately after surgery
Surgery-related complications or death60 months
Currence of stenosis of target lesion60 months
Device-related serious adverse events60 months
Target lesion was treated by interventional or surgical therapy once again60 months

Countries

China

Contacts

Primary ContactMin Li, M.D.
liminyingxiang@163.com13953176057

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026