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Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

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ClinicalTrials.gov Identifier: NCT01883999
Recruitment Status : Active, not recruiting
First Posted : June 21, 2013
Results First Posted : August 3, 2016
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Common Iliac Artery Aneurysms
Aorto-iliac Aneurysms
Intervention Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GORE® EXCLUDER® Iliac Branch Endoprosthesis
Hide Arm/Group Description GORE® EXCLUDER® Iliac Branch Endoprosthesis
Period Title: Overall Study
Started 64
Completed 61
Not Completed 3
Arm/Group Title GORE® EXCLUDER® Iliac Branch Endoprosthesis
Hide Arm/Group Description GORE® EXCLUDER® Iliac Branch Endoprosthesis
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants
69.6  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
1
   1.6%
Male
63
  98.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants
64
1.Primary Outcome
Title Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects initiating IBE procedure and meeting inclusion/exclusion criteria
Arm/Group Title GORE® EXCLUDER® Iliac Branch Endoprosthesis
Hide Arm/Group Description:
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: participants
62
2.Primary Outcome
Title 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
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria
Arm/Group Title GORE® EXCLUDER® Iliac Branch Endoprosthesis
Hide Arm/Group Description:
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: participants
58
3.Secondary Outcome
Title 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)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria
Arm/Group Title GORE® EXCLUDER® Iliac Branch Endoprosthesis
Hide Arm/Group Description:
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: participants
61
Time Frame 6 months or more of follow-up
Adverse Event Reporting Description All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
 
Arm/Group Title GORE® EXCLUDER® Iliac Branch Endoprosthesis
Hide Arm/Group Description GORE® EXCLUDER® Iliac Branch Endoprosthesis
All-Cause Mortality
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Affected / at Risk (%)
Total   25/63 (39.68%) 
Cardiac disorders   
Arteriosclerosis coronary artery * 1  1/63 (1.59%) 
Bradycardia * 1  1/63 (1.59%) 
Cardiac failure congestive * 1  2/63 (3.17%) 
Myocardial infarction * 1  1/63 (1.59%) 
Tachycardia * 1  1/63 (1.59%) 
Ventricular fibrillation * 1  1/63 (1.59%) 
Gastrointestinal disorders   
Diverticular perforation * 1  1/63 (1.59%) 
General disorders   
Stent-graft endoleak * 1  1/63 (1.59%) 
Thrombosis in device * 1  1/63 (1.59%) 
Immune system disorders   
Contrast media allergy * 1  1/63 (1.59%) 
Infections and infestations   
Incision site infection * 1  1/63 (1.59%) 
Otitis media * 1  1/63 (1.59%) 
Pneumonia * 1  1/63 (1.59%) 
Urinary tract infection * 1  3/63 (4.76%) 
Injury, poisoning and procedural complications   
Hip fracture * 1  1/63 (1.59%) 
Urinary retention postoperative * 1  1/63 (1.59%) 
Vascular pseudoaneurysm * 1  1/63 (1.59%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/63 (1.59%) 
Osteoarthritis * 1  1/63 (1.59%) 
Nervous system disorders   
Cerebrovascular accident * 1  1/63 (1.59%) 
Syncope * 1  1/63 (1.59%) 
Renal and urinary disorders   
Urinary retention * 1  1/63 (1.59%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease * 1  1/63 (1.59%) 
Haemoptysis * 1  1/63 (1.59%) 
Hypoxia * 1  2/63 (3.17%) 
Pulmonary embolism * 1  1/63 (1.59%) 
Vascular disorders   
Aortic dissection * 1  1/63 (1.59%) 
Haematoma * 1  1/63 (1.59%) 
Hypotension * 1  1/63 (1.59%) 
Peripheral artery aneurysm * 1  1/63 (1.59%) 
Peripheral artery dissection * 1  1/63 (1.59%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Affected / at Risk (%)
Total   53/63 (84.13%) 
General disorders   
Stent-graft endoleak * 1  27/63 (42.86%) 
Infections and infestations   
Urinary tract infection * 1  4/63 (6.35%) 
Injury, poisoning and procedural complications   
Incision site pain * 1  8/63 (12.70%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  7/63 (11.11%) 
Arthralgia * 1  4/63 (6.35%) 
Renal and urinary disorders   
Urinary retention * 1  5/63 (7.94%) 
Vascular disorders   
Intermittent claudication * 1  6/63 (9.52%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Abe Letter
Organization: W.L. Gore & Associates
Phone: 928-864-3113
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01883999     History of Changes
Other Study ID Numbers: IBE 12-04
First Submitted: June 18, 2013
First Posted: June 21, 2013
Results First Submitted: June 22, 2016
Results First Posted: August 3, 2016
Last Update Posted: December 4, 2018