Recruitment

Recruitment Status
Completed

Inclusion Criteria

Male or infertile female
Life expectancy > 2 years
Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
...
Male or infertile female
Life expectancy > 2 years
Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
Surgical candidate
Age > 21 years
An Informed Consent Form signed by Subject or legally authorized representative
Able to comply with protocol requirements including following-up
Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses

Exclusion Criteria

Dissected, heavily calcified, or heavily thrombosed landing zone(s)
Known sensitivities or allergies to the device materials
New York Heart Association (NYHA) Functional Classification class IV
...
Dissected, heavily calcified, or heavily thrombosed landing zone(s)
Known sensitivities or allergies to the device materials
New York Heart Association (NYHA) Functional Classification class IV
Renal insufficiency defined or patient undergoing dialysis
Systemic infection which may increase the risk of endovascular graft infection
Participating in another investigational device or drug study within 1 year of treatment
Known concomitant thoracic aortic aneurysm which requires intervention
Mycotic or ruptured aneurysm
Planned concomitant surgical procedure or major surgery within 30 days of treatment date
American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
Tortuous or stenotic iliac and/or femoral arteries
Known history of drug abuse
Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome

Summary

Conditions
  • Aorto-iliac Aneurysms
  • Common Iliac Artery Aneurysms
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

Inclusion Criteria

Male or infertile female
Life expectancy > 2 years
Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
...
Male or infertile female
Life expectancy > 2 years
Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
Surgical candidate
Age > 21 years
An Informed Consent Form signed by Subject or legally authorized representative
Able to comply with protocol requirements including following-up
Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses

Exclusion Criteria

Dissected, heavily calcified, or heavily thrombosed landing zone(s)
Known sensitivities or allergies to the device materials
New York Heart Association (NYHA) Functional Classification class IV
...
Dissected, heavily calcified, or heavily thrombosed landing zone(s)
Known sensitivities or allergies to the device materials
New York Heart Association (NYHA) Functional Classification class IV
Renal insufficiency defined or patient undergoing dialysis
Systemic infection which may increase the risk of endovascular graft infection
Participating in another investigational device or drug study within 1 year of treatment
Known concomitant thoracic aortic aneurysm which requires intervention
Mycotic or ruptured aneurysm
Planned concomitant surgical procedure or major surgery within 30 days of treatment date
American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
Tortuous or stenotic iliac and/or femoral arteries
Known history of drug abuse
Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome

Tracking Information

NCT #
NCT01883999
Collaborators
Not Provided
Investigators
  • Principal Investigator: Darren Schneider, MD Weill Medical College of Cornell University
  • Darren Schneider, MD Weill Medical College of Cornell University