Abdominal Aortic AneurysmNCT02308839

GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

An observational study of Abdominal Aortic 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 is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Aortic Aneurysm
What is being tested?: GORE® EXCLUDER® Endoprosthesis
Type of treatment: Medical device
How many people: 181 participants
Where: 1 siteFrance
Study dates: Jul 2012to 5 Oct 2018
How long will I take part?: 5 Years
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 requiring treatemtn with an endoprosthesis for the treatment of an unruptured infra-renal aortic abdominal aneurysm.

Who may be able to join

Any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm.

Who cannot join

Patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).

Trial locations and contacts

1 site in 1 country.

France1 site

Centre Hospitalier de Dijon
Dijon, 21034

Other trials in France

About this study

Official title: Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms

Read the detailed description

The use of abdominal aortic endoprostheses makes the treatment of infra-renal abdominal aortic aneurysms possible, with implantation via the femoral artery, thus avoiding a very invasive surgical procedure. The French National Authority for Health requires a 5-year follow-up as part of the renewal for reimbursement for these endoprostheses.

Conditions: Abdominal Aortic Aneurysm
Being tested: GORE® EXCLUDER® Endoprosthesis
Keywords: Aneurysm, Aorta, Abdominal
Medical subject headings: Aortic Aneurysm, Abdominal, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GORE® EXCLUDER® EndoprosthesisDevice
Endovascular therapy to treat abdominal aortic aneurysms

What is being measured

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

Percentage of Participants Survived at 5 Years
Kaplan-Meier estimate of participant survival at 5 years
Measured: 5 years

Secondary outcomes (6)

Percentage of Participants Free From Endoleak at 5 Years
Kaplan-Meier estimate of participant freedom from endoleak (Type I, II and III) at 5 years
Measured: 5 years
Percentage of Participants Free From Migration at 5 Years
Kaplan-Meier estimate of participant freedom from migration at 5 years
Measured: 5 years
Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years
Kaplan-Meier estimate of participant freedom from aneurysm diameter growth at 5 years
Measured: 5 years
Percentage of Participants Free From Aneurysm Related Mortality at 5 Years
Kaplan-Meier estimate of participant freedom from aneurysm related mortality at 5 years
Measured: 5 years
Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years
Kaplan-Meier estimate of participant freedom from endovascular or surgical re-intervention at 5 years
Measured: 5 years
Percentage of Participants Free From Surgical Conversion at Procedure
Participant freedom from surgical conversion at procedure
Measured: Index Procedure

Timeline

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

Jul 20125 Oct 2018

First posted4 Dec 2014 (estimated)
Study startJul 2012
Primary completion26 Sep 2018
Study completion5 Oct 2018

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 Abdominal Aortic 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: Prospective
Enrolment: 181 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02308839
Sponsor's protocol ID: FPR12-02
Status last verified: May 2020
First submitted: 21 Nov 2014
Last updated: 22 May 2020
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

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

All Abdominal Aortic Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the GORE® EXCLUDER® Endoprosthesis in the Treatment of Infra-renal Abdominal Aortic Aneurysms
ClinicalTrials.gov ID: NCT02308839
Acronym / sponsor ID: FPR12-02
Conditions: Abdominal Aortic Aneurysm
Keywords: Aneurysm, Aorta, Abdominal
Study type: Observational
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Jul 2012 (actual)
Primary completion: 26 Sep 2018 (actual)
Study completion: 5 Oct 2018 (actual)
First posted: 4 Dec 2014 (estimated)
Results: Posted 22 May 2020

Clinical summary

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients requiring treatemtn with an endoprosthesis for the treatment of an unruptured infra-renal aortic abdominal aneurysm.

Key inclusion criteria (1 listed)

Any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm.

Key exclusion criteria (1 listed)

Patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).

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® EXCLUDER® EndoprosthesisEndovascular therapy to treat abdominal aortic aneurysms	Device	–

Primary outcome

Percentage of Participants Survived at 5 Years
Time frame: 5 years
Kaplan-Meier estimate of participant survival at 5 years

6 secondary outcomes

Percentage of Participants Free From Endoleak at 5 Years
Time frame: 5 years
Percentage of Participants Free From Migration at 5 Years
Time frame: 5 years
Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years
Time frame: 5 years
Percentage of Participants Free From Aneurysm Related Mortality at 5 Years
Time frame: 5 years
Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years
Time frame: 5 years
Percentage of Participants Free From Surgical Conversion at Procedure
Time frame: Index Procedure

Results and safety

Results posted to the registry on 22 May 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
GORE® EXCLUDER® AAA Endoprosthesis	181	72

Primary outcome: Percentage of Participants Survived at 5 Years

Time frame: 5 years. Number. Unit: Percentage of participants alive

Measure	GORE® EXCLUDER® AAA Endoprosthesis n = 181
Value	76

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Five year follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GORE® EXCLUDER® AAA Endoprosthesis	69 of 181 (38.1%)	89 of 181 (49.2%)	35 of 181

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Abdominal Aortic Aneurysm

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

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.

Eric Steinmetz, Prof principal investigator

Centre Hospitalier Universitaire du Bocage

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 Abdominal Aortic 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 1 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 22 May 2020. 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 22 May 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?

Percentage of Participants Survived at 5 Years (time frame: 5 years). 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 NCT02308839.

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 22 May 2020.