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CompletedNCT01883999Updated Nov 2, 2021Results posted

Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

An interventional study of GORE® EXCLUDER® Iliac Branch Endoprosthesis in Common Iliac Artery Aneurysms and Aorto-iliac Aneurysms, sponsored by W.L.Gore & Associates. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-11-02.

Sponsored by W.L.Gore & Associates · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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).

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Conditions studied

  • Common Iliac Artery Aneurysms
  • Aorto-iliac Aneurysms
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In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 174 are open to participants now.

This study's enrollment of 64 is below the median of 72 across 461 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

W.L.Gore & Associates is the lead sponsor of 95 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
  2. Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
  3. An Informed Consent Form signed by Subject or legally authorized representative
  4. Male or infertile female
  5. Able to comply with protocol requirements including following-up
  6. Life expectancy > 2 years
  7. Age > 21 years
  8. Surgical candidate

Exclusion criteria

Exclusion Criteria:

  1. Mycotic or ruptured aneurysm
  2. Known concomitant thoracic aortic aneurysm which requires intervention
  3. American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
  4. Renal insufficiency defined or patient undergoing dialysis
  5. New York Heart Association (NYHA) Functional Classification class IV
  6. Dissected, heavily calcified, or heavily thrombosed landing zone(s)
  7. Tortuous or stenotic iliac and/or femoral arteries
  8. Participating in another investigational device or drug study within 1 year of treatment
  9. Systemic infection which may increase the risk of endovascular graft infection
  10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  11. Planned concomitant surgical procedure or major surgery within 30 days of treatment date
  12. Known history of drug abuse
  13. Known sensitivities or allergies to the device materials
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    GORE® EXCLUDER® Iliac Branch Endoprosthesis

    GORE® EXCLUDER® Iliac Branch Endoprosthesis

    Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis

Interventions

  • DeviceGORE® EXCLUDER® Iliac Branch Endoprosthesis
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days post-treatment

  2. 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.

    Time frame: 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).

    Time frame: Through 6 month follow-up visit

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Results

Posted Aug 3, 2016

Participant flow

Participant flow — Overall Study
MilestoneGORE® EXCLUDER® Iliac Branch Endoprosthesis
Started64
Completed61
Not completed3

Outcome measures

PrimaryFreedom 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.

Time frame:
30 days post-treatment
Reported as:
Number · participants
Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair
participantsGORE® EXCLUDER® Iliac Branch Endoprosthesis
Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair62
PrimaryFreedom 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.

Time frame:
Through 6 month follow-up visit
Reported as:
Number · participants
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
participantsGORE® EXCLUDER® Iliac Branch Endoprosthesis
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 IIC58
SecondaryFreedom 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).

Time frame:
Through 6 month follow-up visit
Reported as:
Number · participants
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)
participantsGORE® EXCLUDER® Iliac Branch Endoprosthesis
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)61

Adverse events

Collected over 6 months or more of follow-up. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GORE® EXCLUDER® Iliac Branch Endoprosthesis—25/63 (39.7%)53/63 (84.1%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventGORE® EXCLUDER® Iliac Branch Endoprosthesis
Urinary tract infectionInfections and infestations3/63
Cardiac failure congestiveCardiac disorders2/63
HypoxiaRespiratory, thoracic and mediastinal disorders2/63
Arteriosclerosis coronary arteryCardiac disorders1/63
BradycardiaCardiac disorders1/63
Myocardial infarctionCardiac disorders1/63
TachycardiaCardiac disorders1/63
Ventricular fibrillationCardiac disorders1/63
Diverticular perforationGastrointestinal disorders1/63
Stent-graft endoleakGeneral disorders1/63
Most frequent other events
Most frequent other events
EventGORE® EXCLUDER® Iliac Branch Endoprosthesis
Stent-graft endoleakGeneral disorders27/63
Incision site painInjury, poisoning and procedural complications8/63
Back painMusculoskeletal and connective tissue disorders7/63
Intermittent claudicationVascular disorders6/63
Urinary retentionRenal and urinary disorders5/63
Urinary tract infectionInfections and infestations4/63
ArthralgiaMusculoskeletal and connective tissue disorders4/63

Baseline characteristics

Age, Continuous
Age, Continuous(years)GORE® EXCLUDER® Iliac Branch Endoprosthesis
Mean69.6 ± 8.4
Sex: Female, Male
Sex: Female, Male(Participants)GORE® EXCLUDER® Iliac Branch Endoprosthesis
Female1
Male63
Region of Enrollment
Region of Enrollment(participants)GORE® EXCLUDER® Iliac Branch Endoprosthesis
United States64
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Study locations

1 site
  • Weill Cornell Medical Center
    New York, New York 10065, United States
09

References and documents

Publications

  • 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01883999
Lead sponsor
W.L.Gore & Associates
Responsible party
Sponsor
First posted
Jun 21, 2013
Start date
Oct 2013
Primary completion
Apr 2016
Completion
Jun 2021
Results posted
Aug 3, 2016
Last update
Nov 2, 2021

Study contacts

Darren Schneider, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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