Active clinical trials for "Aneurysm"

The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.

The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.

Endovascular treatment of ruptured and unruptured intracranial aneurysms presents complications, mainly the thrombo-embolic complication. No specific studies have been conducted to study factors associated with the occurrence of thromboembolic complications (symptomatic or not) post endovascular treatment of intracranial aneurysms.

This is an observational trial to determine if use of fusion imaging in infrarenal endovascular aneurysm repair will decrease the radiation dose and improve patient safety for this procedure.

Rupture of abdominal aortic aneurysms(AAA) causes 12,000 deaths/year in the UK.1 Elective repair to prevent this carries a perioperative mortality of 4.5% for open surgery and 1% for endovascular repair. This risk is associated with poor cardiorespiratory fitness which can be measured using Cardiopulmonary Exercise Testing(CPET) with the CPET variables, peak oxygen uptake(peakVO2)<15ml/kg/min and anaerobic threshold(AT)<10.2ml/kg/min identifying patients at increased risk of early death after AAA repair.3 These variables can therefore be used as surrogate markers for cardiovascular fitness and risk of mortality and morbidity in AAA surgery; optimising these markers should improve fitness and decrease this risk. The optimal duration and type of exercise training for improving peak VO2 and AT in AAA patients is not known. AAA patients are unique as they are motivated to reduce the risk of impending surgery but are afforded the time to improve their fitness as repair may not be needed for months or even years. The investigators propose a pilot randomised controlled trial to explore the effectiveness of a 20-week community (either home or gym-based) exercise programme to achieve sustained improvements in peak VO2 and AT, as measured by CPET, in AAA patients. Changes in QoL, habitual activity levels and cardiovascular risk will also be assessed. The results will inform a definitive multicentre clinical trial on exercise to improve outcomes in elderly patients with cardiovascular disease and AAA.

The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms.

A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.

Ischemia/reperfusion injury following aortic cross-clamping for vascular surgery leads to systemic hemodynamic and microcirculatory perturbances. The use of different anesthetic regimens may have an impact on tissue perfusion. The aim of this study was to explore changes in microvascular perfusion in patients undergoing elective open abdominal aortic aneurysm repair under balanced or total intravenous anesthesia. Prospective observational study on 40 patients scheduled for elective open infrarenal abdominal aortic aneurysm repair, who received balanced (desflurane + remifentanil, n=20) or total intravenous anesthesia (TIVA, propofol + remifentanil using target-controlled infusion, n=20) according to the clinician's decision. A goal-directed hemodynamic management was applied in all patients. Hemodynamics and arterial/venous blood gases were compared before anesthesia induction (baseline) and at end-surgery. Changes in sublingual microvascular flow and density were assessed with incident dark field illumination imaging. Near infrared spectroscopy was applied on the thenar eminence with a vascular occlusion test (VOT) to assess variations in the peripheral muscle tissue oxygenation and microcirculatory reactivity.

The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits associated with using the Ovation Prime Abdominal Stent Graft System under the least invasive conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR protocol include: appropriate patient selection, bilateral percutaneous access, no general anesthesia, no ICU admission post procedure, and next day discharge.

INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.