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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE® EXCLUDER® Iliac Branch Endoprosthesis | Experimental | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® EXCLUDER® Iliac Branch Endoprosthesis | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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:
| Through 6 month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through 6 month follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Schneider, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35842202 | Derived | 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. | |
| 30064841 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE® EXCLUDER® Iliac Branch Endoprosthesis | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE® EXCLUDER® Iliac Branch Endoprosthesis | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects initiating IBE procedure and meeting inclusion/exclusion criteria | Posted | Number | participants | 30 days post-treatment |
|
|
6 months or more of follow-up
All follow-up at time of endpoint calculation for subjects undergoing IBE Device procedure (6 months post-treatment and later if available)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GORE® EXCLUDER® Iliac Branch Endoprosthesis | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stent-graft endoleak | General disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abe Letter | W.L. Gore & Associates | 928-864-3113 | aletter@wlgore.com |
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| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | 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:
| Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria | Posted | Number | participants | Through 6 month follow-up visit |
|
|
|
| Secondary | 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). | Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria | Posted | Number | participants | Through 6 month follow-up visit |
|
|
|
| 25 |
| 63 |
| 53 |
| 63 |
| Bradycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Diverticular perforation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Stent-graft endoleak | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Contrast media allergy | Immune system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Incision site infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Peripheral artery dissection | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
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