Recruitment

Recruitment Status
Active, not recruiting

Inclusion Criterias

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

Exclusion Criterias

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

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 Criterias

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

Exclusion Criterias

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

Locations

New York, New York, 10065
New York, New York, 10065

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