Popliteal AneurysmVAP-AURCNCT03996889
Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery
An observational study of Popliteal Aneurysm, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Popliteal Aneurysm
- What is being tested?
- Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2019to Sep 2022
- 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: The study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic.
Who may be able to join
- > 18 years old at time of treatment
- symptomatic or asymptomatic popliteal artery aneurysm needing surgery
- scheduled elective surgery
Who cannot join
- life expectancy of <1 year
- thrombotic occlusion of popliteal artery
- intolerance to antiplatelet drugs (antiaggregants)
- known allergies to GORE VIABAHN® stent graft materials/composition
- emergency surgery
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL)
Bron, 69677
Nellie DELLA SCHIAVA, MD, 4 72 11 76 76 ext. +33, dellaschiava.nellie@neuf.fr
Nellie DELLA SCHIAVA, MD
About this study
Official title: Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)
This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC)
- Conditions
- Popliteal Aneurysm
- Being tested
- Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery
- Medical subject headings
- Popliteal Artery Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgeryDevice
The intervention can be performed under local anesthesia (LA), regional locus (ALR) or general anesthesia (AG) (data collected) by first approach: percutaneous or conventional.
The data collected are:
- Number of GORE VIABAHN® stent used (length and diameter of each)
- Embolization of collaterals and other related actions
- Operative complications
- Intraoperative fibrinolysis
- Collar cover> 2 cm
- Lack of overlap in the "overlap zone" (nb: between 4 and 8 cm above the joint spacing)
- Arteriography in profile, kink
| Study group | Role | What they receive |
|---|---|---|
| Popliteal aneurysm patients with GORE VIABAHN® | The study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic. Receives: Device: Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major limb events
Composite criterion associating Target Lesion Revascularization (TLR) and Rate of major amputation.
An Echo-Doppler imaging examination will be performed and the following parameters and information should be collected:
- Permeability
- Intra-stent restenosis
- Systolic pressure index
Measured: 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Popliteal AneurysmStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996889
- Sponsor's protocol ID
- VAP-AURC
- Acronym
- VAP-AURC
- Status last verified
- Jul 2019
- First submitted
- 21 Jun 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)
- ClinicalTrials.gov ID
- NCT03996889
- Acronym / sponsor ID
- VAP-AURC / VAP-AURC
- Conditions
- Popliteal Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 25 Jun 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.
This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Popliteal aneurysm patients with GORE VIABAHN® | – | Device: Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgeryThe study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic.
Key inclusion criteria (3 listed)
- > 18 years old at time of treatment
- symptomatic or asymptomatic popliteal artery aneurysm needing surgery
- scheduled elective surgery
Key exclusion criteria (5 listed)
- life expectancy of <1 year
- thrombotic occlusion of popliteal artery
- intolerance to antiplatelet drugs (antiaggregants)
- known allergies to GORE VIABAHN® stent graft materials/composition
- emergency surgery
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 treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgeryThe intervention can be performed under local anesthesia (LA), regional locus (ALR) or general anesthesia (AG) (data collected) by first approach: percutaneous or conventional. The data collected are: * Number of GORE VIABAHN® stent used (length and diameter of each) * Embolization of collaterals and other related actions * Operative complications * Intraoperative fibrinolysis * Collar cover> 2 cm * Lack of overlap in the "overlap zone" (nb: between 4 and 8 cm above the joint spacing) * Arteriography in profile, kink | Device | Popliteal aneurysm patients with GORE VIABAHN® |
Primary outcome
Major limb events
Time frame: 2 years of follow-up
Composite criterion associating Target Lesion Revascularization (TLR) and Rate of major amputation. An Echo-Doppler imaging examination will be performed and the following parameters and information should be collected: * Permeability * Intra-stent restenosis * Systolic pressure index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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?
An observational study of Popliteal Aneurysm, run by Hospices Civils de Lyon 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 3 inclusion and 5 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 8 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nellie DELLA SCHIAVA, MD (4 72 11 76 76 ext. +33, dellaschiava.nellie@neuf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major limb events (time frame: 2 years of follow-up). 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 8 Jul 2019.