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  • AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion Rochester, Minn. To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.
  • Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression (ADVANCE) Rochester, Minn.

    The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms.  

  • GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study Rochester, Minn., Scottsdale/Phoenix, Ariz. This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.
  • IMPRoving Outcomes in Vascular DisEase- Aortic Dissection (IMPROVE-AD) Rochester, Minn.

    The purpose of this study is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy, with surveillance for deterioration in patients with uncomplicated type B aortic dissection.

  • SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study (SAVE-FistulaS) Rochester, Minn. This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
  • Zenith® Fenestrated+ Endovascular Graft Clinical Study Rochester, Minn.

    The primary objective of this study is to evaluate the safety and effectiveness of the Zenith® Fenestrated+Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) for the treatment of patients with aortic aneurysms, where the device sealing zone requires fenestrations with connections to one or more of the major
    visceral arteries.  
    Secondary outcomes, evaluated for descriptive purposes (not for statistical inference) include the assessment of procedural variables and clinical utility measures (see secondary outcomes).

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