Artery InjuryNCT03872323
Open and Endovascular Surgical Treatment for Artery Injuries
A study testing Endovascular treatment and Open surgery in people with Artery Injury, run by Jinan Military General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Artery Injury
- What is being tested?
- Endovascular treatment and Open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- Bleeding can be easily control; There is contraindications for surgical operation. -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
960 Hospital of PLA
Jinan, Shandong, 250031
Min Li, M.D.
About this study
Official title: 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.
- Conditions
- Artery Injury
- Being tested
- Endovascular treatment, Open surgery
- Keywords
- Artery Injury, Surgery, Endovascular Repair, Peripheral Arteries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatmentProcedure or surgery
The arteries injuries are repaired by endovascular treatment.
Open surgeryProcedure or surgery
The arteries injuries are repaired by open surgical operation.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment | Active comparator | Not described Receives: Procedure: Endovascular treatment |
| Open surgery | Active comparator | Not described Receives: Procedure: Open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year treatment success rate
Treatment success is defined as restored blood flow without clinical complications.
Measured: 60 months
Secondary outcomes (5)
Technically success rate of surgery
Measured: immediately after surgery
Surgery-related complications or death
Measured: 60 months
Currence of stenosis of target lesion
Measured: 60 months
Device-related serious adverse events
Measured: 60 months
Target lesion was treated by interventional or surgical therapy once again
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artery InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan Military General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Min, Jinan Military General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872323
- Sponsor's protocol ID
- 960HP20190045
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Open and Endovascular Surgical Techniques to Manage Vascular Injuries
- ClinicalTrials.gov ID
- NCT03872323
- Acronym / sponsor ID
- 960HP20190045
- Conditions
- Artery Injury
- Keywords
- Artery Injury, Surgery, Endovascular Repair, Peripheral Arteries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jinan Military General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment | Active comparator | Procedure: Endovascular treatment |
| Open surgery | Active comparator | Procedure: Open surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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. -
Key exclusion criteria (1 listed)
- Bleeding can be easily control; There is contraindications for surgical operation. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatmentThe arteries injuries are repaired by endovascular treatment. | Procedure or surgery | Endovascular treatment |
| Open surgeryThe arteries injuries are repaired by open surgical operation. | Procedure or surgery | Open surgery |
Primary outcome
5-year treatment success rate
Time frame: 60 months
Treatment success is defined as restored blood flow without clinical complications.
5 secondary outcomes
Technically success rate of surgery
Time frame: immediately after surgery
Surgery-related complications or death
Time frame: 60 months
Currence of stenosis of target lesion
Time frame: 60 months
Device-related serious adverse events
Time frame: 60 months
Target lesion was treated by interventional or surgical therapy once again
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment and Open surgery in people with Artery Injury, run by Jinan Military General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Li, M.D. (13953176057, liminyingxiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year treatment success rate (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.