Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
Last updated on April 2022Recruitment
- 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