Aorto-iliac Aneurysms, Common Iliac Artery Aneurysms
Conditions
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).
Interventions
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | 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) | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE® EXCLUDER® Iliac Branch Endoprosthesis GORE® EXCLUDER® Iliac Branch Endoprosthesis | 64 |
| Total | 64 |
Baseline characteristics
| Characteristic | GORE® EXCLUDER® Iliac Branch Endoprosthesis |
|---|---|
| Age, Continuous | 69.6 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment United States | 64 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 63 |
| serious Total, serious adverse events | 25 / 63 |
Outcome results
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.
Time frame: 30 days post-treatment
Population: Subjects initiating IBE procedure and meeting inclusion/exclusion criteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® 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 Repair | 62 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: * 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
Population: Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® 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 IIC | 58 participants |
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).
Time frame: Through 6 month follow-up visit
Population: Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® 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 participants |