A Study to Assess the GORE® EXCLUDER® Conformable Endoprosthesis for the Treatment of Abdominal Aortic Aneurysms

Overview

About this study

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to repair an  aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria

  • Abdominal Aortic Aneurism meeting any of the following criteria
    • Maximum diameter ≥50 mm
    • Rapid growth >5 mm in a 6 month period
    • Non-ruptured AAA presenting with clinical symptoms
  • Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including
    • Adequate iliac / femoral access
    • Infrarenal aortic neck diameter 16-32 mm
    • Infrarenal aortic neck length ≥10 mm
    • Aortic neck angle ≤ 90˚
    • Distal iliac artery seal zone ≥10 mm
    • Iliac artery diameter 8-25 mm
  • An Informed Consent Form (ICF) signed by subject
  • Male or infertile female
  • Able to comply with protocol requirements including following-up
  • Life expectancy > 2 years
  • Age ≥ 21 years

Exclusion Criteria

  • Mycotic or ruptured aneurysm
  • Known concomitant thoracic aortic aneurysm which requires surgical intervention
  • Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis
  • New York Heart Association (NYHA) class IV
  • Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
  • Severely tortuous or stenotic iliac and / or femoral arteries
  • Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
  • Participating in another investigational device or drug study within 1 year of treatment
  • Systemic infection which may increase the risk of endovascular graft infection
  • 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
  • Known history of drug abuse
  • Known sensitivities or allergies to the device materials

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Gustavo Oderich, M.D.

Open for enrollment

Contact information:

Alisa Diderrich R.N.

(507)538-8152

Diderrich.Alisa@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20201661

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