N/A
Completed N=64
Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
Common Iliac Artery Aneurysms · Aorto-iliac Aneurysms
Source: ClinicalTrials.gov NCT01883999 ↗
Enrolled (actual)
64
Serious AEs
39.7%
Results posted
Aug 2016
Primary outcomePrimary: Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair — 62 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair |
62 | — |
| 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 |
58 | — |
| 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) |
61 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01883999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.