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Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Rochester, MN
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.
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Zenith® p-Branch® OTS Multicenter Study
Rochester, MN
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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Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
Rochester, MN
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 Study of the Zenith(R) Low Profile AAA Endovascular Graft
Rochester, MN
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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Long Term Health Care Utilization Analysis of Open and Endovascular Abdominal Aortic Aneurysm Repair
Rochester, MN
The purpose of this study is to compare the utilization of healthcare resources between open surgical and endovascular repair of infrarenal abdominal aortic aneurysms.
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A Study to Compare Radiation Exposures between Two Standard-of-care Methods of Abdominal Aortic Aneurysm Repair
Scottsdale/Phoenix, AZ
The study is being done to compare radiation exposure between two standard-of-care methods of abdominal aortic aneurysm repair.
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A Study to Assess Outcomes of Patients Treated with AFX System Compared to Other EVAR Devices
Jacksonville, FL
The purpose of this study is to evaluate Endologix AFX endovascular abdominal aortic aneurism system with anatomical fixation against other approved endovascular systems with proximal fixation.
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Complex Aortic Aneurysm Repair With Fenestrated Stent Grafts
Rochester, MN
This study will compare two groups of subjects with complex abdominal aortic aneurysms. It will compare their clinical outcomes and quality of life measures. The group being treated in this study will have their aneurysms repaired by an endovascular approach using Zenith® Fenestrated AAA Endovascular Graft. This group will be compared to a group of 461 patients (historical cohort) whose complex aneurysms were treated by open surgical repair.
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A Study of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta.
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Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Rochester, MN
Prospective, non-randomized, , multicenter study with two independent arms:
* Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis.
* Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only
* Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis.
Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)
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Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression (ADVANCE Trial)
Rochester, MN
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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Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression (ADVANCE Trial)
Jacksonville, FL
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. Subjects will be randomized and imaging will be collected at all follow-up time points to assess the primary endpoint.
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Brain and Abdominal Aneurysm Study
Jacksonville, FL; Rochester, MN
Aneurysmal subarachnoid hemorrhage (aSAH) is the most deadly kind of stroke. Each year, 40,000 Americans have SAH. Case-fatality approaches 60% and more than half of those who die do so before reaching the hospital. Most commonly, SAH results from rupture of an intracranial aneurysm. Screening high-risk individuals could identify those at greatest risk and decrease the devastating effect of SAH. Aortic Aneurysm also constitutes a major public health problem with high lethality. Current estimates are that ruptured aortic aneurysm kills 13,000 Americans each year. Screening efforts have effectively lowered mortality from aortic aneurysm rupture but a high proportion of those ...
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Clinical Outcomes of Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms
Rochester, MN
This is a prospective, non-randomized, single center, data collection study of patients treated with open surgical repair (OR) for complex aortic aneurysms (CAAs).
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A Study to Evaluate the Effectiveness of Nicotinamide Riboside and Pterostilbene Treatment to Protect the Kidneys in Patients with Complex Aortic Aneurysm Repair and Aortic Arch Reconstruction
Rochester, MN
The purpose of this study is to determine the effectiveness of Basis™ (Nicotinamide Riboside and Pterostilbene) in preventing acute kidney injury (AKI) among patients undergoing complex aortic aneurysm repair and aortic arch reconstruction.