Popliteal Artery AneurysmPAA 12-01NCT01902888
Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm
An observational study of Popliteal Artery Aneurysm, run by W.L.Gore & Associates at 3 sites in United States.
Trial summary
This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Popliteal Artery Aneurysm
- What is being tested?
- GORE® VIABAHN® Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2013to Apr 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 who had popliteam aneurysm and were treated with GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010.
Who may be able to join
- Received a GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010 to treat a popliteal artery aneurysm;
- Had an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or symptomatic aneurysm (no diameter requirement) of the popliteal artery, or the presence of mural thrombus (no diameter requirement) of the popliteal artery;
- Was 18 years of age or older; and
- Had an elective popliteal artery aneurysm procedure.
Who cannot join
- Bilateral popliteal artery aneurysms with initial treatment on the same day
- Had previous surgery for the popliteal artery aneurysm in the study limb
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baptist Health
Miami, Florida
The Vascular Group of Naples
Naples, Florida
Washington University School of Medicine
St Louis, Missouri
About this study
Official title: Retrospective Evaluation of the GORE® VIABAHN® Endoprosthesis for a Popliteal Artery Aneurysm Indication
This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).
Read the detailed description
The primary objective is to evaluate the safety and efficacy of the GORE® VIABAHN® Endoprosthesis for the treatment of subjects with Popliteal Artery Aneurysms. The study population includes subjects with an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, symptomatic aneurysm (no diameter requirement) of the popliteal artery, or presence of mural thrombus (no diameter requirement) of the popliteal artery treated with the GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010. Starting with most recently treated within the above date range, patients meeting Inclusion/Exclusion will be enrolled, until a minimum of 50 subjects with adequate follow up to determine primary endpoints through 12 months will be provided.
- Conditions
- Popliteal Artery Aneurysm
- Being tested
- GORE® VIABAHN® Endoprosthesis
- Keywords
- popliteal artery, aneurysm, popliteal artery aneurysm, asymptomatic aneurysm, mural thrombus, Viabahn, Gore, Endoprosthesis
- Medical subject headings
- Popliteal Artery Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® VIABAHN® EndoprosthesisDevice
Also called Viabahn
| Study group | Role | What they receive |
|---|---|---|
| Popliteal aneurysm | GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm Receives: Device: GORE® VIABAHN® Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.
A composite of freedom from failure of technical success or loss of primary patency at 12 months
Measured: 12 months following initial study procedure
Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure.
30 day serious adverse events related to the initial study procedure or the study device.
Measured: 30 days following initial study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Closed due to internal and external factors.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Popliteal Artery AneurysmStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hector Novoa, BS, Study director, W. L. Gore & Associates, Inc (sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902888
- Sponsor's protocol ID
- PAA 12-01
- Acronym
- PAA 12-01
- Status last verified
- Jun 2015
- First submitted
- 16 Jul 2013
- Last updated
- 19 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the GORE® VIABAHN® Endoprosthesis for a Popliteal Artery Aneurysm Indication
- ClinicalTrials.gov ID
- NCT01902888
- Acronym / sponsor ID
- PAA 12-01 / PAA 12-01
- Conditions
- Popliteal Artery Aneurysm
- Keywords
- popliteal artery, aneurysm, popliteal artery aneurysm, asymptomatic aneurysm, mural thrombus, Viabahn, Gore, Endoprosthesis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Closed due to internal and external factors.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Posted 19 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).
Detailed description
The primary objective is to evaluate the safety and efficacy of the GORE® VIABAHN® Endoprosthesis for the treatment of subjects with Popliteal Artery Aneurysms. The study population includes subjects with an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, symptomatic aneurysm (no diameter requirement) of the popliteal artery, or presence of mural thrombus (no diameter requirement) of the popliteal artery treated with the GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010. Starting with most recently treated within the above date range, patients meeting Inclusion/Exclusion will be enrolled, until a minimum of 50 subjects with adequate follow up to determine primary endpoints through 12 months will be provided.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Popliteal aneurysm | – | Device: GORE® VIABAHN® EndoprosthesisGORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had popliteam aneurysm and were treated with GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010.
Key inclusion criteria (4 listed)
- Received a GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010 to treat a popliteal artery aneurysm;
- Had an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or symptomatic aneurysm (no diameter requirement) of the popliteal artery, or the presence of mural thrombus (no diameter requirement) of the popliteal artery;
- Was 18 years of age or older; and
- Had an elective popliteal artery aneurysm procedure.
Key exclusion criteria (2 listed)
- Bilateral popliteal artery aneurysms with initial treatment on the same day
- Had previous surgery for the popliteal artery aneurysm in the study limb
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® EndoprosthesisAlso: Viabahn | Device | Popliteal aneurysm |
Primary outcome
Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.
Time frame: 12 months following initial study procedure
A composite of freedom from failure of technical success or loss of primary patency at 12 months
Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure.
Time frame: 30 days following initial study procedure
30 day serious adverse events related to the initial study procedure or the study device.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hector Novoa, BS study director
W. L. Gore & Associates, Inc (sponsor)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Popliteal Artery Aneurysm, run by W.L.Gore & Associates at 3 sites in United States.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency. (time frame: 12 months following initial study procedure). The study lists 2 primary outcomes in all. 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 19 Jun 2015.