- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03872323
Open and Endovascular Surgical Treatment for Artery Injuries
March 11, 2019 updated by: Li Min, Jinan Military General Hospital
Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Min Li, M.D.
- Phone Number: 13953176057
- Email: liminyingxiang@163.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250031
- Recruiting
- 960 Hospital of PLA
-
Contact:
- Min Li, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Open surgery
|
The arteries injuries are repaired by open surgical operation.
|
Active Comparator: Endovascular treatment
|
The arteries injuries are repaired by endovascular treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
5-year treatment success rate
Time Frame: 60 months
|
Treatment success is defined as restored blood flow without clinical complications.
|
60 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Technically success rate of surgery
Time Frame: immediately after surgery
|
immediately after surgery
|
Surgery-related complications or death
Time Frame: 60 months
|
60 months
|
Currence of stenosis of target lesion
Time Frame: 60 months
|
60 months
|
Device-related serious adverse events
Time Frame: 60 months
|
60 months
|
Target lesion was treated by interventional or surgical therapy once again
Time Frame: 60 months
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2019
Primary Completion (Anticipated)
April 30, 2024
Study Completion (Anticipated)
January 1, 2026
Study Registration Dates
First Submitted
March 11, 2019
First Submitted That Met QC Criteria
March 11, 2019
First Posted (Actual)
March 13, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 960HP20190045
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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