Popliteal Artery AneurysmNCT02462876

Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)

An observational study of Popliteal Artery Aneurysm, run by W.L.Gore & Associates at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms. 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: 60 participants
Where: 1 siteFrance
Study dates: Oct 2015to Dec 2020
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 with a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or presence of mural thrombus (< 2 cm) in the popliteal artery treated since the date of reimbursement in France.

Who may be able to join

Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm
Had a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or the presence of mural thrombus (< 2 cm) in the popliteal artery;
Was 18 years of age or older at the time of the treatment;
Had an elective popliteal artery aneurysm procedure;
Has provided Informed Consent, personally or through lawful representation as determined by applicable local regulations and state law

Who cannot join

Prior to or at the time of implant the patient is / has:
Bilateral popliteal artery aneurysms with initial treatment on the same day;
Thrombotic occlusion of the popliteal artery or PAA;
Marfan syndrome or Ehlers-Danlos syndrome;
Unable to tolerate antiplatelet therapy;
Thrombophilia requiring long term anticoagulation;
Known allergies to the GORE® VIABAHN® Endoprosthesis components;
Enrolled in another investigational drug or medical device trial where participation may have affected the outcome or treatment of the subject in the popliteal artery aneurysm study with the GORE® VIABAHN® Endoprosthesis or had previous surgery for the popliteal artery aneurysm in the study limb.

Trial locations and contacts

1 site in 1 country.

France1 site

Hôpitaux Universitaire de Strasbourg
Strasbourg

Other trials in France

About this study

Official title: Post-market Study: Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm

This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.

Conditions: Popliteal Artery Aneurysm
Being tested: GORE® VIABAHN® Endoprosthesis
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.

GORE® VIABAHN® EndoprosthesisDevice
Treatment of Popliteal Artery Aneurysm with the GORE® VIABAHN® Endoprosthesis.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Primary Patency at 12 Months
Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months.
Measured: 12 months
Number of Subjects With a Safety-related Event at 12 Months
Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months
Measured: 12 months

Secondary outcomes (9)

Probability of Primary Patency
Primary patency is defined as blood flow without occlusion maintained through the device after implant without an intervention. This outcome is estimated through Kaplan-Meier analysis
Measured: 12, 24, and 36 months
Number of Subject With a Safety-related Event at 24 and 36 Months
Safety-related events are defined as serious adverse events and adverse events related to study procedure or study device through 24 and 36 months.
Measured: 24 and 36 months
Length of Hospital Stay
The number of days the subject remains in the hospital due to endovascular repair of a popliteal artery aneurysm
Measured: During hospitalization, approximately 1-2 days
Length of Procedure
The number of minutes the subject remains in the operating room or catheterization laboratory due to endovascular repair of a popliteal artery aneurysm.
Measured: During procedure, approximately 120 minutes
Probability of Primary Assisted Patency
Primary assisted patency is defined as blood flow maintained through the device after implant regardless of repeat interventions performed (without occlusion). This outcome is estimated through Kaplan-Meier analysis.
Measured: 12, 24, and 36 months
Probability of Freedom From Limb Loss
Limb loss is defined as the amputation of the study limb above the metatarsals. This outcome is estimated through Kaplan-Meier analysis.
Measured: 12, 24, and 36 months
Probability of Freedom From Repeat Intervention
Repeat Intervention is defined as any endovascular or surgical procedure performed to treat a stenosis or occlusion with the study device(s) or within 5 millimeters of the proximal or distal edge of the device(s), treatment of endoleaks or other reasons. This outcome is estimated through Kaplan-Meier analysis.
Measured: 12, 24, and 36 months
Probability of Secondary Patency
Secondary patency is defined as blood flow through the device regardless of repeat interventions performed (with or without occlusion) and freedom from surgical bypass. This outcome is estimated through Kaplan-Meier analysis.
Measured: 12, 24, and 36 months
Number of Subjects With Technical Success
Technical success is defined as successful aneurysmal exclusion using the study device at time of the procedure without Type I or III endoleaks that require post-procedure intervention within 30 days.
Measured: Post-procedure at day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Dec 2020

First posted4 Jun 2015 (estimated)
Study startOct 2015
Primary completionJul 2018
Study completionDec 2020

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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02462876
Sponsor's protocol ID: FPR14-03
Status last verified: Mar 2022
First submitted: 29 May 2015
Last updated: 28 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Peripheral Artery Disease, Popliteal Aneurysm
Active, not recruitingObservational study
Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm
Aortic Aneurysm, Abdominal, Popliteal Artery Aneurysm
Recruiting
Prospective Case-control Study in Patients With PAA
Popliteal Artery Aneurysm, Peripheral Arterial Disease

All Popliteal Artery Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market Study: Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm
ClinicalTrials.gov ID: NCT02462876
Acronym / sponsor ID: FPR14-03
Conditions: Popliteal Artery Aneurysm
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Oct 2015 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Dec 2020 (actual)
First posted: 4 Jun 2015 (estimated)
Results: Posted 13 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or presence of mural thrombus (< 2 cm) in the popliteal artery treated since the date of reimbursement in France.

Key inclusion criteria (5 listed)

Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm
Had a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or the presence of mural thrombus (< 2 cm) in the popliteal artery;
Was 18 years of age or older at the time of the treatment;
Had an elective popliteal artery aneurysm procedure;
Has provided Informed Consent, personally or through lawful representation as determined by applicable local regulations and state law

Key exclusion criteria (8 listed)

Bilateral popliteal artery aneurysms with initial treatment on the same day;
Thrombotic occlusion of the popliteal artery or PAA;
Marfan syndrome or Ehlers-Danlos syndrome;
Unable to tolerate antiplatelet therapy;
Thrombophilia requiring long term anticoagulation;

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® EndoprosthesisTreatment of Popliteal Artery Aneurysm with the GORE® VIABAHN® Endoprosthesis.	Device	–

Primary outcome

Number of Subjects With Primary Patency at 12 Months
Time frame: 12 months
Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months.
Number of Subjects With a Safety-related Event at 12 Months
Time frame: 12 months
Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months

9 secondary outcomes

Probability of Primary Patency
Time frame: 12, 24, and 36 months
Number of Subject With a Safety-related Event at 24 and 36 Months
Time frame: 24 and 36 months
Length of Hospital Stay
Time frame: During hospitalization, approximately 1-2 days
Length of Procedure
Time frame: During procedure, approximately 120 minutes
Probability of Primary Assisted Patency
Time frame: 12, 24, and 36 months
Probability of Freedom From Limb Loss
Time frame: 12, 24, and 36 months
Probability of Freedom From Repeat Intervention
Time frame: 12, 24, and 36 months
Probability of Secondary Patency
Time frame: 12, 24, and 36 months
Number of Subjects With Technical Success
Time frame: Post-procedure at day 30

Results and safety

Results posted to the registry on 13 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Viabahn	60	33

Primary outcome: Number of Subjects With Primary Patency at 12 Months

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Viabahn n = 51
Patent at 12 Months	40
Not Patent	11

Population analysed: Includes all subjects who lost patency within 12 months and all patent subjects with at least a 12 month visit or later.

Primary outcome: Number of Subjects With a Safety-related Event at 12 Months

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Viabahn n = 56
No Event	29
Event(s)	27

Population analysed: Includes all subjects who have a serious adverse event or adverse event related to study procedure or device within 12 months and all subjects free from those events with at least a 12 month visit or later.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VIABAHN® Endoprosthesis	32 of 60 (53.3%)	0 of 60 (0%)	3 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Popliteal Artery Aneurysm

Active, not recruitingObservational study
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Peripheral Artery Disease, Popliteal Aneurysm
Active, not recruitingObservational study
Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm
Aortic Aneurysm, Abdominal, Popliteal Artery Aneurysm
Recruiting
Prospective Case-control Study in Patients With PAA
Popliteal Artery Aneurysm, Peripheral Arterial Disease

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.

Nabil Chakfé principal investigator

Hôpitaux Universitaire de Strasbourg

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 Artery Aneurysm, run by W.L.Gore & Associates 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 5 inclusion and 8 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 28 Mar 2022. 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?

Yes. Results are posted in the registry (first posted 13 Jul 2020). 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?

Number of Subjects With Primary Patency at 12 Months (time frame: 12 months). 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?

On the ClinicalTrials.gov record for NCT02462876.

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 28 Mar 2022.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (5 listed)

Key exclusion criteria (8 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Number of Subjects With Primary Patency at 12 Months

Primary outcome: Number of Subjects With a Safety-related Event at 12 Months

Adverse events

Research links

Related trials for Popliteal Artery Aneurysm

Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm

Prospective Case-control Study in Patients With PAA

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Number of Subjects With Primary Patency at 12 Months

Primary outcome: Number of Subjects With a Safety-related Event at 12 Months

Adverse events