Nellix Registry Study: EVAS-Global
Abdominal Aortic AneurysmMulticenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)
Thoraflex Hybrid Post-Market Study
Acute Aortic DissectionAortic Rupture4 moreThis is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic aneurysm.
Assessment of Risk in Thoracic Aortopathy Using 18F-Sodium Fluoride
Bicuspid Aortic ValveThoracic Aortic Aneurysm1 morePatients with bicuspid aortic valve-related aortopathy are at increased risk of aortic dilatation, dissection and rupture. Currently, risk stratification is largely based on aortic diameter measurements, with those deemed high risk referred for aortic replacement surgery. This approach is imperfect, and potentially exposes many patients to unnecessary high-risk aortic surgery, or fails to identify those at risk of dissection or rupture with smaller diameters. In patients with abdominal aortic aneurysms, the investigators recently demonstrated that uptake of 18F-sodium fluoride predicts disease progression and clinical events independent of aneurysm diameter and standard clinical risk factors. Based on the investigators preliminary data, a study was proposed to look at 18F-sodium fluoride uptake in patients with bicuspid aortic valve-related aortopathy. The proposed study will shed light on the underlying pathological processes involved in aortic complications of this disease as well as potentially providing an important risk marker to predict disease progression and guide the need for major aortic surgery.
International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular...
Intracranial AneurysmIMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.
Open Versus Endovascular Repair of Popliteal Artery Aneurysm Trial
Popliteal Artery AneurysmWeakness in the wall of a blood vessel located behind the knee (popliteal artery) which leads to a swelling of this blood vessel (aneurysm) is one of the most common types of arterial aneurysms. It is associated with significant risk of blood clot formation, narrowing of blood vessel which can create a serious threat to individual's health. Currently, approved treatment options for this condition include both open surgical and endovascular stent-graft repairs. In the open repair procedure, the blood vessel behind the knee is tied up or removed and a small artery is created using a vein on the same leg. This is also called a bypass procedure. In the endovascular repair, using X-rays, doctors places a stent in the blood vessel. Stent is a small device similar to a thin tube. When it is placed in the right location, your doctor can open it. When stent is opened, it supports weakened blood vessel and blood goes through it. The weakened artery then shrinks around the stent. The OVER-PAR is a short name for this study. Many hospitals in the United States agreed to participate in this study. Patients are randomized to undergo either open or endovascular repair because they can be treated with either of the procedures. Investigators use the short names OPAR for open surgical repair and EPAR for endovascular repair. People who have an aneurysm that is larger than 2 cm (about an inch) can participate in this study. The purpose of this study is to compare outcomes after these two standard procedures.
AneuRx Post Market Study in the Treatment of AAA
Abdominal AneurysmThe aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion that has been treated in recent year via endovascular repair. The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft Systems.
Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery
Peripheral Vascular DiseaseAbdominal Aortic AneurysmAggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery. The purpose of this study is to compare the tight versus traditional blood glucose control in diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections, overall morbidity and 30-day mortality.
Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device...
Thoracoabdominal Aortic AneurysmThe primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.
FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
Intracranial AneurysmA prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
Global Fenestrated Anaconda Clinical sTudy
Abdominal Aortic AneurysmThis study is a prospective non-interventional, multi-centre study of the Vascutek Fenestrated Anaconda™ system, and is essentially a post-market study. The Vascutek Fenestrated Anaconda™ system is a custom made device used for the treatment of Abdominal Aortic Aneurysm.