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.

Completed

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

Official record

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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

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)

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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

Other trials in United States

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

Conditions: Common Iliac Artery Aneurysms, Aorto-iliac Aneurysms
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 groups in NCT01883999
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.

Oct 2013Jun 2021

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)

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 35842202
Schneider 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

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

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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

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