Common Iliac Artery AneurysmsNCT01883999
Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
A study testing GORE® EXCLUDER® Iliac Branch Endoprosthesis in people with Common Iliac Artery Aneurysms and Aorto-iliac Aneurysms, run by W.L.Gore & Associates at 1 site in United States.
Trial summary
The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Common Iliac Artery Aneurysms, Aorto-iliac Aneurysms
- What is being tested?
- GORE® EXCLUDER® Iliac Branch Endoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2021
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
- Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
- An Informed Consent Form signed by Subject or legally authorized representative
- Male or infertile female
- Able to comply with protocol requirements including following-up
- Life expectancy > 2 years
- Age > 21 years
- Surgical candidate
Who cannot join
- Mycotic or ruptured aneurysm
- Known concomitant thoracic aortic aneurysm which requires intervention
- American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
- Renal insufficiency defined or patient undergoing dialysis
- New York Heart Association (NYHA) Functional Classification class IV
- Dissected, heavily calcified, or heavily thrombosed landing zone(s)
Show all 13Show fewer
- Tortuous or stenotic iliac and/or femoral arteries
- Participating in another investigational device or drug study within 1 year of treatment
- Systemic infection which may increase the risk of endovascular graft infection
- Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
- Planned concomitant surgical procedure or major surgery within 30 days of treatment date
- Known history of drug abuse
- Known sensitivities or allergies to the device materials
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical Center
New York, New York, 10065
About this study
Official title: Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms
The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).
- Being tested
- GORE® EXCLUDER® Iliac Branch Endoprosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® EXCLUDER® Iliac Branch EndoprosthesisDevice
| Study group | Role | What they receive |
|---|---|---|
| GORE® EXCLUDER® Iliac Branch Endoprosthesis | Experimental | GORE® EXCLUDER® Iliac Branch Endoprosthesis Receives: Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair
Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.
Measured: 30 days post-treatment
Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC
Freedom from all of the following:
- Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC).
- Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory
- Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC.
Measured: Through 6 month follow-up visit
Secondary outcomes (1)
Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)
Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).
Measured: Through 6 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2016
- Study completionJun 2021
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Common Iliac Artery AneurysmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Schneider, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883999
- Sponsor's protocol ID
- IBE 12-04
- Status last verified
- Oct 2021
- First submitted
- 18 Jun 2013
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schneider DB, Matsumura JS, Lee JT, Peterson BG, Chaer RA, Oderich GS. Five-year outcomes from a prospective, multicenter study of endovascular repair of iliac artery aneurysms using an iliac branch device. J Vasc Surg. 2023 Jan;77(1):122-128. doi: 10.1016/j.jvs.2022.07.006. Epub 2022 Jul 13.
PubMed 35842202Schneider DB, Milner R, Heyligers JMM, Chakfe N, Matsumura J. Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings. J Vasc Surg. 2019 Feb;69(2):367-377.e1. doi: 10.1016/j.jvs.2018.05.200. Epub 2018 Jul 29.
PubMed 30064841
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms
- ClinicalTrials.gov ID
- NCT01883999
- Acronym / sponsor ID
- IBE 12-04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Posted 3 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE® EXCLUDER® Iliac Branch Endoprosthesis | Experimental | Device: GORE® EXCLUDER® Iliac Branch EndoprosthesisGORE® EXCLUDER® Iliac Branch Endoprosthesis |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
- Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
- An Informed Consent Form signed by Subject or legally authorized representative
- Male or infertile female
- Able to comply with protocol requirements including following-up
Key exclusion criteria (13 listed)
- Mycotic or ruptured aneurysm
- Known concomitant thoracic aortic aneurysm which requires intervention
- American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
- Renal insufficiency defined or patient undergoing dialysis
- New York Heart Association (NYHA) Functional Classification class IV
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® Iliac Branch Endoprosthesis | Device | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
Primary outcome
Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair
Time frame: 30 days post-treatment
Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.
Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC
Time frame: Through 6 month follow-up visit
Freedom from all of the following: * Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC). * Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory * Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC.
1 secondary outcome
Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)
Time frame: Through 6 month follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35842202Schneider DB, Matsumura JS, Lee JT, Peterson BG, Chaer RA, Oderich GS. Five-year outcomes from a prospective, multicenter study of endovascular repair of iliac artery aneurysms using an iliac branch device. J Vasc Surg. 2023 Jan;77(1):122-128. doi: 10.1016/j.jvs.2022.07.006. Epub 2022 Jul 13.
- Derived from this study: PubMed 30064841Schneider DB, Milner R, Heyligers JMM, Chakfe N, Matsumura J. Outcomes of the GORE Iliac Branch Endoprosthesis in clinical trial and real-world registry settings. J Vasc Surg. 2019 Feb;69(2):367-377.e1. doi: 10.1016/j.jvs.2018.05.200. Epub 2018 Jul 29.
Related trials for Common Iliac Artery Aneurysms
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Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization
Common Iliac Artery Aneurysm, Aorto Iliac Aneurysm
Active, not recruiting
The Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System
Common Iliac Artery 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.
Darren Schneider, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GORE® EXCLUDER® Iliac Branch Endoprosthesis in people with Common Iliac Artery Aneurysms and Aorto-iliac Aneurysms, run by W.L.Gore & Associates at 1 site 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 8 inclusion and 13 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 2 Nov 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 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 3 Aug 2016). 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?
Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair (time frame: 30 days post-treatment). 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 NCT01883999, which also lists 2 linked publications.
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 2 Nov 2021.