Clinical trial NCT01883999: Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
Official title: Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Iliac Artery Aneurysms
Aorto-iliac Aneurysms
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2013-06-21
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair
timeFrame: 30 days post-treatment
measure: 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
timeFrame: Through 6 month follow-up visit
Secondary outcomes:
measure: 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)
timeFrame: Through 6 month follow-up visit
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Darren Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.