Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GORE® EXCLUDER® Iliac Branch Endoprosthesis GORE® EXCLUDER® Iliac Branch Endoprosthesis |
Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis
|
Outcome Measures
Primary Outcome Measures
- Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair [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 [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.
Secondary Outcome Measures
- 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) [Through 6 month follow-up visit]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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)
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Cornell Medical Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- W.L.Gore & Associates
Investigators
- Principal Investigator: Darren Schneider, MD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IBE 12-04
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
|---|---|
| Arm/Group Description | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
| Period Title: Overall Study | |
| STARTED | 64 |
| COMPLETED | 61 |
| NOT COMPLETED | 3 |
Baseline Characteristics
| Arm/Group Title | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
|---|---|
| Arm/Group Description | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
| Overall Participants | 64 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
69.6
(8.4)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1
1.6%
|
| Male |
63
98.4%
|
| Region of Enrollment (participants) [Number] | |
| United States |
64
100%
|
Outcome Measures
| Title | Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects initiating IBE procedure and meeting inclusion/exclusion criteria |
| Arm/Group Title | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
|---|---|
| Arm/Group Description | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
| Measure Participants | 62 |
| Number [participants] |
62
96.9%
|
| 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 |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria |
| Arm/Group Title | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
|---|---|
| Arm/Group Description | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
| Measure Participants | 61 |
| Number [participants] |
58
90.6%
|
| 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) |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria |
| Arm/Group Title | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
|---|---|
| Arm/Group Description | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
| Measure Participants | 61 |
| Number [participants] |
61
95.3%
|
Adverse Events
| 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 | |
| Arm/Group Description | GORE® EXCLUDER® Iliac Branch Endoprosthesis | |
All Cause Mortality |
||
| GORE® EXCLUDER® Iliac Branch Endoprosthesis | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| GORE® EXCLUDER® Iliac Branch Endoprosthesis | ||
| Affected / at Risk (%) | # Events | |
| Total | 25/63 (39.7%) | |
| Cardiac disorders | ||
| Arteriosclerosis coronary artery | 1/63 (1.6%) | |
| Bradycardia | 1/63 (1.6%) | |
| Cardiac failure congestive | 2/63 (3.2%) | |
| Myocardial infarction | 1/63 (1.6%) | |
| Tachycardia | 1/63 (1.6%) | |
| Ventricular fibrillation | 1/63 (1.6%) | |
| Gastrointestinal disorders | ||
| Diverticular perforation | 1/63 (1.6%) | |
| General disorders | ||
| Stent-graft endoleak | 1/63 (1.6%) | |
| Thrombosis in device | 1/63 (1.6%) | |
| Immune system disorders | ||
| Contrast media allergy | 1/63 (1.6%) | |
| Infections and infestations | ||
| Incision site infection | 1/63 (1.6%) | |
| Otitis media | 1/63 (1.6%) | |
| Pneumonia | 1/63 (1.6%) | |
| Urinary tract infection | 3/63 (4.8%) | |
| Injury, poisoning and procedural complications | ||
| Hip fracture | 1/63 (1.6%) | |
| Urinary retention postoperative | 1/63 (1.6%) | |
| Vascular pseudoaneurysm | 1/63 (1.6%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 1/63 (1.6%) | |
| Osteoarthritis | 1/63 (1.6%) | |
| Nervous system disorders | ||
| Cerebrovascular accident | 1/63 (1.6%) | |
| Syncope | 1/63 (1.6%) | |
| Renal and urinary disorders | ||
| Urinary retention | 1/63 (1.6%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Chronic obstructive pulmonary disease | 1/63 (1.6%) | |
| Haemoptysis | 1/63 (1.6%) | |
| Hypoxia | 2/63 (3.2%) | |
| Pulmonary embolism | 1/63 (1.6%) | |
| Vascular disorders | ||
| Aortic dissection | 1/63 (1.6%) | |
| Haematoma | 1/63 (1.6%) | |
| Hypotension | 1/63 (1.6%) | |
| Peripheral artery aneurysm | 1/63 (1.6%) | |
| Peripheral artery dissection | 1/63 (1.6%) | |
Other (Not Including Serious) Adverse Events |
||
| GORE® EXCLUDER® Iliac Branch Endoprosthesis | ||
| Affected / at Risk (%) | # Events | |
| Total | 53/63 (84.1%) | |
| General disorders | ||
| Stent-graft endoleak | 27/63 (42.9%) | |
| Infections and infestations | ||
| Urinary tract infection | 4/63 (6.3%) | |
| Injury, poisoning and procedural complications | ||
| Incision site pain | 8/63 (12.7%) | |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 7/63 (11.1%) | |
| Arthralgia | 4/63 (6.3%) | |
| Renal and urinary disorders | ||
| Urinary retention | 5/63 (7.9%) | |
| Vascular disorders | ||
| Intermittent claudication | 6/63 (9.5%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Abe Letter |
|---|---|
| Organization | W.L. Gore & Associates |
| Phone | 928-864-3113 |
| aletter@wlgore.com |
- IBE 12-04