Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

Aorto-iliac Aneurysms Clinical Trial

Official title:

Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883999
• Other study ID #: IBE 12-04
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: June 2021

Study information

• Verified date: October 2021
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2021
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aorto-iliac Aneurysms
• Common Iliac Artery Aneurysms
• Iliac Aneurysm

Intervention

Device:
• GORE® EXCLUDER® Iliac Branch Endoprosthesis

Locations

Country	Name	City	State
United States	Weill Cornell Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	30 days post-treatment
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.	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).	Through 6 month follow-up visit