Aneurysms or Occlusive Disease of the Abdominal AortaWOBIFNCT05055102
Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta.
An observational study of Aneurysms or Occlusive Disease of the Abdominal Aorta, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The Wovex bifurcated dacron vascular prostheses have been available on the French market since 2008. They are mainly used to treat aneurysmal or occlusive aortic diseases. To date, they have not been the subject of a specific clinical efficacy/safety study, unlike other Dacron prostheses used in the same field. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysms or Occlusive Disease of the Abdominal Aorta
- What is being tested?
- Data collection
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2021to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between January, 1st 2013 and December 31, 2017 who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) from LEMAITRE VASCULAR Society
Who may be able to join
- Subject is volontarily agree to participation
- Patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between January, 1st 2013 and December 31, 2017 who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) from LEMAITRE VASCULAR Society
Who cannot join
- Deceased patients who have expressed their refusal of post-mortem processing of their personal health data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta
The Wovex bifurcated dacron vascular prostheses have been available on the French market since 2008. They are mainly used to treat aneurysmal or occlusive aortic diseases. To date, they have not been the subject of a specific clinical efficacy/safety study, unlike other Dacron prostheses used in the same field.
We purpose a monocentric, retrospective, consecutive study based on medical data, including all the patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between 2013 and 2017 and who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses).
The objective is to explore the safety (short-term postoperative morbidity and mortality at 5 years) and efficacy (primary permeability, secondary permeability and dilatation of the prosthesis at 5 years) of the WOVEX prosthesis.
- Being tested
- Data collection
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
demographics co-morbidities risk factors operative, hospital and vascular follow-up data
| Study group | Role | What they receive |
|---|---|---|
| Patient with WOVEX bifurcated prosthesis | * Patients who have undergone open abdominal aortic surgery between January 1st, 2013 and December 31, 2017 in Burgundy Dijon Hospital.
* Patients who have been treated with a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and security
Occurrence of death or major re-intervention (bypass stenosis/thrombosis, false anastomotic aneurysm, prosthesis infection, anastomosis rupture, amputation) over the entire follow-up period (from date of surgery to study end date (February 28, 2021))
Measured: 5 years
Secondary outcomes (6)
Major surgical reintervention
bypass stenosis/thrombosis, false anastomotic aneurysm, prosthesis infection, anastomosis rupture, amputation throughout the follow-up period
Measured: 5 years
Primary permeability
Stenosis/thrombosis of the prosthesis over the entire follow-up period
Measured: 5 years
Secondary permeability
Stenosis/thrombosis after reintervention over the entire follow-up period
Measured: 5 years
Dilatation of the prothesis
Diameter of the prosthesis over the entire follow-up period
Measured: 5 years
Occurence of MAVE and MACE
Occurence of MAVE and MACCE (re-interventions, ischemic cardiac, neurological (stroke/TIA), pulmonary and renal complications) throughout the follow-up period
Measured: 5 years
Occurence of adverse events
Other adverse events over the entire follox-up period
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start16 Jan 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysms or Occlusive Disease of the Abdominal AortaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055102
- Sponsor's protocol ID
- STEINMETZ LEMAITRE 2020
- Acronym
- WOBIF
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 24 Sep 2021
- 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 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta
- ClinicalTrials.gov ID
- NCT05055102
- Acronym / sponsor ID
- WOBIF / STEINMETZ LEMAITRE 2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 24 Sep 2021 (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 Wovex bifurcated dacron vascular prostheses have been available on the French market since 2008. They are mainly used to treat aneurysmal or occlusive aortic diseases. To date, they have not been the subject of a specific clinical efficacy/safety study, unlike other Dacron prostheses used in the same field.
We purpose a monocentric, retrospective, consecutive study based on medical data, including all the patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between 2013 and 2017 and who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses).
The objective is to explore the safety (short-term postoperative morbidity and mortality at 5 years) and efficacy (primary permeability, secondary permeability and dilatation of the prosthesis at 5 years) of the WOVEX prosthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with WOVEX bifurcated prosthesis | – | Other: Data collection* Patients who have undergone open abdominal aortic surgery between January 1st, 2013 and December 31, 2017 in Burgundy Dijon Hospital. * Patients who have been treated with a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between January, 1st 2013 and December 31, 2017 who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) from LEMAITRE VASCULAR Society
Key inclusion criteria (2 listed)
- Subject is volontarily agree to participation
- Patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between January, 1st 2013 and December 31, 2017 who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) from LEMAITRE VASCULAR Society
Key exclusion criteria (1 listed)
- Deceased patients who have expressed their refusal of post-mortem processing of their personal health data
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 |
|---|---|---|
| Data collectiondemographics co-morbidities risk factors operative, hospital and vascular follow-up data | Other | Patient with WOVEX bifurcated prosthesis |
Primary outcome
Safety and security
Time frame: 5 years
Occurrence of death or major re-intervention (bypass stenosis/thrombosis, false anastomotic aneurysm, prosthesis infection, anastomosis rupture, amputation) over the entire follow-up period (from date of surgery to study end date (February 28, 2021))
6 secondary outcomes
Major surgical reintervention
Time frame: 5 years
Primary permeability
Time frame: 5 years
Secondary permeability
Time frame: 5 years
Dilatation of the prothesis
Time frame: 5 years
Occurence of MAVE and MACE
Time frame: 5 years
Occurence of adverse events
Time frame: 5 years
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 24 Sep 2021.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysms or Occlusive Disease of the Abdominal Aorta, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 24 Sep 2021. 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 France. 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?
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?
Safety and security (time frame: 5 years). 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 24 Sep 2021.