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Aneurysm clinical trials

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NCT ID: NCT01883999 Completed - Clinical trials for Aorto-iliac Aneurysms

Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

Start date: October 2013
Phase: N/A
Study type: Interventional

The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).

NCT ID: NCT01882634 Completed - Clinical trials for Abdominal Aortic Aneurysm

Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care

BarcelonAAA
Start date: June 2013
Phase: Phase 0
Study type: Interventional

To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60 years through a screening program in Primary Health Care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with AAA.

NCT ID: NCT01878240 Completed - Clinical trials for Abdominal Aortic Aneurysm

Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac

SCOPE1
Start date: May 2013
Phase: N/A
Study type: Interventional

Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death. Federal funding through Medicare has been allocated for early detection using abdominal ultrasound screening programs. Despite these more aggressive screening programs and concerted efforts by surgeons for timely repair, the incidence of ruptured AAA has continued to increase. Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006. Multiple studies reflecting decreased perioperative morbidity and mortality over open repair make this an attractive option for patients. EVAR requires more intensive follow-up than standard open surgical repair, however. Secondary interventions are more common to maintain "seal" of the endograft within the aorta and subsequent exclusion of the aneurysmal component. The term endoleak is specific to EVAR, and describes the primary means by which endografts fail. Type I endoleaks occur because of inadequate graft seal proximally or distally, resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to collateral flow. Type III endoleaks occur when flow persists between segments of a modular graft. Type IV endoleaks occur when flow persists through endograft material (graft porosity). Type V endoleaks have also been called "endotension", and occur when pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and Type III endoleaks are most concerning for rupture, although persistent Type II endoleaks can also lead to aneurysm rupture and premature death. The most common method of EVAR follow-up is computed tomographic angiography (CTA). These studies allow accurate measurement of aneurysm sac diameters and volumes. They also are highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain persistent and are present in the setting of aneurysm sac enlargement. Type I and III endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with current endograft technology.

NCT ID: NCT01863524 Completed - Clinical trials for Acute Coronary Syndrome

Screening for Abdominal Aortic Aneurysm Using a Portable Transthoracic Echocardiography Among Patients With Acute Coronary Syndrome

Start date: May 2013
Phase: N/A
Study type: Observational

The prevalence of Abdominal Aortic Aneurysm among 65 years old individuals worldwide is 1-2%. when diagnosis is confirmed by abdominal Ultrasound the prevalence is 5.5% in men and 1% in women. As abdominal aortic aneurysm and coronary heart disease share common risk factors, patients with acute coronary syndrome represent a high risk population in which screening for another atherosclerotic site is recommended. Patients admitted for ACS undergo routinely TTE. during the same study, TTE may offer the opportunity to evaluate the cardiac morphology and function and to screen for Abdominal Aortic aneurysm. It was reported by different studies that the Sensitivity of this technique was between 91-96% for AAA screening. In addition, this method is cheap, available and requires only 2-3 minutes to be added to the standard TTE. we plan to examine patients admitted with ACS in our Intensive Care Unit for screening AAA by TTE in subcostal views in addition to the standard TTE examination.

NCT ID: NCT01850732 Completed - Clinical trials for Abdominal Aortic Aneurysm

Screening of Abdominal Aortic Aneurysms Among Male Patients With TIA Symptoms

Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the prevalence of abdominal aortic aneurysms (AAA) among male patients with transient ischemic attack (TIA) symptoms. Ethiology of AAA is known to be common with atherosclerotic arterial diseases (coronary artery disease, peripheral artery disease and carotid artery disease), so the hypothesis is that AAA should be more common among these TIA patients, thus making screening of these patients (for AAA) more cost-efficient. Study will be carried out as a prospective screening study. Data will be collected in North Karelia Central Hospital within one year. All male patients with TIA symptoms will be recruited for the study and screened for AAA with ultrasound.

NCT ID: NCT01843322 Completed - Aortic Aneurysm Clinical Trials

Endoleak Repair Guided by Navigation Technology

Start date: April 2011
Phase: N/A
Study type: Interventional

The study is aimed at investigating whether repair of endoleak type II can be improved by adding navigation technology. Can this technology increase precision by guiding the needle that punctures through the skin as used during the repair procedure? Can the procedure logistics be improved by using navigation technology instead of computed tomography (CT) guidance of the needle puncture? Parameters logged during the procedure: - was the needle placement successful? - number of needle punctures? - time used on guidance procedure - X-ray exposure dose

NCT ID: NCT01839695 Completed - Clinical trials for Thoracic Aortic Aneurysms

Safety and Efficacy of Valiant Mona LSA Stent Graft System

Start date: April 2013
Phase: N/A
Study type: Interventional

The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to assess safety and performance of the device acutely and at 30 days.

NCT ID: NCT01824654 Completed - Clinical trials for Aortic Aneurysm, Abdominal

Enhanced Guidance for Endovascular Repair of Abdominal Aortic Aneurysm

AAA 2D/3D II
Start date: April 2013
Phase: N/A
Study type: Interventional

An increasing incidence of abdominal aortic aneurysms (AAA) is observed in our ageing population. Since it is less invasive, endovascular repair (EVAR) by stent-graft (SG) insertion is frequently indicated in patients with intermediate and high-operative risk. Patient selection and stent planning for EVAR is done on CT-scans based on specific anatomic criteria. SG are inserted in the catheterization laboratory under digital substraction angiography (DSA) and fluoroscopic guidance. With this technology, no soft-tissue differentiation is available during the intervention and important information are lacking such as thrombus and aneurysm extension close to proximal and distal landing zones. Our team has recently patented a software allowing the extraction of the AAA (lumen and thrombus) from pre-operative CT-scanner. In collaboration with Siemens medical, the investigators have integrated this technology to the Siemens workstation in the catheterization laboratory. The investigators can now import the aortic lumen and thrombus meshes segmented from pre-operative CT-scans and perform a rigid registration with fluoroscopy and DSA data to enhance visualization of soft tissue during EVAR. Our preliminary results are encouraging in terms of feasibility and visualization. However, the delivery device of the SG and the guidewire used during the intervention are stiff and induce a deformation of aortic lumen and thrombus. This deformation impairs the accuracy of rigid registration. The investigators propose to improve registration accuracy by implementing an elastic deformation of aortic lumen and wall based on the segmentation of endovascular devices (delivery device, guidewires and catheters) inserted during the procedure and by biomechanical modeling.

NCT ID: NCT01811134 Completed - Clinical trials for Intracranial Aneurysm

Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms

EVIDENCE
Start date: November 2012
Phase: N/A
Study type: Interventional

Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.

NCT ID: NCT01810250 Completed - Clinical trials for Abdominal Aortic Aneurysms With Challenging Anatomy

Endurant for Challenging Anatomy: Global Experience Registry

EAGLE
Start date: November 2012
Phase:
Study type: Observational [Patient Registry]

The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database. This study aims at answering two major questions: 1. Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm? 2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?