Iatrogenic Vessel InjuryNCT05183399
Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries
An observational study of Iatrogenic Vessel Injury, run by W.L.Gore & Associates.
Trial summary
The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter "VB device") for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iatrogenic Vessel Injury
- What is being tested?
- GORE® VIABAHN® Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 14 Feb 2021
- Phase
- Observational
- 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
Study population: Patients with traumatic or iatrogenic vessel injuries in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries ) with a reference vessel diameter ranging from 4.0 to 12.0mm.
Patients with traumatic or iatrogenic vessel injuries in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries ) with a reference vessel diameter ranging from 4.0 to 12.0mm.
About this study
Official title: Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries in Thoracic, Abdominal, and Pelvic Arteries
The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter "VB device") for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries).
- Conditions
- Iatrogenic Vessel Injury
- Being tested
- GORE® VIABAHN® Endoprosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® VIABAHN® EndoprosthesisDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
A technical success is defined as is a successful device implantation and a successful hemostasis.
Measured: Day 1 to 1 Month
Secondary outcomes (1)
Safety
The safety Endpoint is the occurrence of serious adverse events and deficiencies.
Measured: Day 1 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Dec 2016
- Primary completion19 May 2017
- Study completion14 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iatrogenic Vessel InjuryStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183399
- Sponsor's protocol ID
- JPS 16-04
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries in Thoracic, Abdominal, and Pelvic Arteries
- ClinicalTrials.gov ID
- NCT05183399
- Acronym / sponsor ID
- JPS 16-04
- Conditions
- Iatrogenic Vessel Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 14 Feb 2021 (actual)
- First posted
- 10 Jan 2022 (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.
The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter "VB device") for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with traumatic or iatrogenic vessel injuries in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries ) with a reference vessel diameter ranging from 4.0 to 12.0mm.
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 |
|---|---|---|
| GORE® VIABAHN® Endoprosthesis | Device | – |
Primary outcome
Technical Success
Time frame: Day 1 to 1 Month
A technical success is defined as is a successful device implantation and a successful hemostasis.
1 secondary outcome
Safety
Time frame: Day 1 to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Vessel Injury, run by W.L.Gore & Associates.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Day 1 to 1 Month). 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 10 Jan 2023.