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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.
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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.
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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.
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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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Closed for Enrollment
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A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
Rochester, Minn.
The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).
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A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries (IMPERIAL)
Rochester, Minn.
The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.
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Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
Rochester, Minn.
The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.
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Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (SSB 11-02)
Rochester, Minn.
The purpose of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending, chest area aorta.
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Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms
Rochester, Minn.
The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA).
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Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
Rochester, Minn.
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.
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Outcomes After Thoracic Endovascular Aortic Repair of Blunt Traumatic Thoracic Aortic Injury – Follow-up study
Rochester, Minn.
The purpose of this study is to retrospectively review experiences with thoracic endovascular aortic repair (TEVAR) of blunt traumatic thoracic aortic injury (BTAI) and to define the long-term outcomes from endovascular management at a single vascular center.
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Popliteal Artery Entrapment Syndrome (PAES) Prospective Registry (PAES)
Rochester, Minn.
The purpose of this study is to develop a prospective registry to collect long-term outcome data of patients undergoing surgical management of popliteal artery entrapment syndrome through surveys
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Zenith® p-Branch® Multicenter Study
Rochester, Minn.
The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).
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Zenith® p-Branch® Pivotal Study
Rochester, Minn.
The purpose of the Zenith® p-Branch® Pivotal clinical trial is to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
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