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Aortic Aneurysm, Abdominal clinical trials

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NCT ID: NCT02345005 Active, not recruiting - Aneurysm Clinical Trials

Iliac Branch Excluder ReGistry (IceBERG)

IceBERG
Start date: November 2014
Phase:
Study type: Observational [Patient Registry]

This post market registry consists of a retrospective and a prospective part. The first part is a retrospective registry of all implanted IBE devices of Gore in the Netherlands after CE mark was obtained, to get an initial insight on the feasibility and safety of this procedure. The second part is to prospectively register all data on implanted IBE Gore devices, in order to gain more robust data on the efficacy of the device in maintaining hypogastric artery patency.

NCT ID: NCT02308839 Completed - Clinical trials for Abdominal Aortic Aneurysm

GORE® EXCLUDER® Endoprosthesis French Mandatory Registry

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

This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).

NCT ID: NCT02306304 Completed - Clinical trials for Abdominal Aortic Aneurysm (AAA)

Ultra-sound for AAA Screening in Smoking Israeli Arab Men

Start date: January 2015
Phase: N/A
Study type: Interventional

The study aims at screening Israeli Arab men, smokers or past smokers, for abdominal aortic aneurysms (AAA). The screening is to be performed at the family doctors clinics in the rural arab erea of the north of Israel. Goals: The investigators aim at revealing the actual prevalence of AAA in the Israeli Arab smoking men population. By revealing this prevalence we believe the need for a nation-wide screening program for AAA will turn available for assessment. In addition, the goal of improving the accessibility of health services for the Israeli Arab population is a key issue in the design of the research. 2000 patients are to be enrolled in the study over a period of 2 years. Each of the patients will be examined once for a duplex ultra-sound and will be classified into one of 4 sub-groups according to the maximal aortic diameter found.

NCT ID: NCT02295137 Recruiting - Clinical trials for Abdominal Aortic Aneurysm (AAA)

Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair

Start date: February 2014
Phase: Phase 1
Study type: Interventional

Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular techniques are used to treat patients with more complex pathology by using custom-made devices and additional stents. In order to accomplish the technical success on advanced EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of contrast and radiation, compared to conventional EVAR. This study is to assess the feasibility of proper visceral and renal arteries catheterization using a 3D model obtained from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the contrast use and patient radiation exposure while achieving procedure success during Advanced EVAR.

NCT ID: NCT02292667 Recruiting - Pain Clinical Trials

Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery

ETAP
Start date: January 2015
Phase: Phase 3
Study type: Interventional

The ETAP study aim to assess the effect of the addition of an ultrasound-guided transversus abdominis plane (TAP) block to a multimodal intravenous analgesia protocol on the postoperative pain control in open surgical repair of abdominal aortic aneurysm. The ETAP study is a single-center open-label randomized controlled trial. Half of patients included will receive the association of TAP block and multimodal intravenous analgesia, and the other half will receive the multimodal intravenous analgesia alone. The multimodal intravenous analgesia includes intravenous paracetamol and intravenous patient-controlled analgesia with morphine.

NCT ID: NCT02266719 Enrolling by invitation - Clinical trials for Aortic Aneurysm, Abdominal

Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices

Start date: December 1, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the clinical outcomes and radiation of the use of off-the-shelf and custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms in patients having appropriate anatomy. The study consists of three cohorts. The first 2 cohorts are the continuation of the current IDE study. The first cohort is aimed to assess the use of custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy (Fenestrated-CMD cohort). The second cohort (Type I-III thoracoabdominal cohort) includes standard and high-risk patients with type I- III thoracoabdominal aneurysms that require the use of branched/fenestrated CMDs, or, in selected cases, the Zenith Thoracoabdominal Branch (Zenith® t-Branchâ„¢) device. Finally, the third cohort (the Arch cohort) will include 25 high-risk patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop

NCT ID: NCT02229006 Completed - Clinical trials for Abdominal Aortic Aneurysm

Sodium Fluoride Imaging of Abdominal Aortic Aneurysms

SoFIA3
Start date: September 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to help predict the rate of abdominal aortic aneurysm expansion.

NCT ID: NCT02225756 Recruiting - Clinical trials for Small Abdominal Aortic Aneurysm

Cyclosporine A in Patients With Small Diameter Abdominal Aortic Aneurysms

ACA4
Start date: December 2013
Phase: Phase 2
Study type: Interventional

Aneurysms of the aorta are dilatations of the main artery in the body that distributes blood to organs. Aneurysms expose patients to aortic rupture. The risk of aortic rupture is high for large aneurysms, and low for small aneurysms. Currently, if the diameter of a small aneurysm grows up to a level at risk for rupture, surgery is indicated to prevent rupture. A drug that would stop growth of small aneurysms would obviate aortic surgery, the current treatment to prevent aortic rupture in patients. The ACA4 study aims at testing the possibility to stop growth of small aortic aneurysms in the abdomen with a drug, cyclosporine A. Patients with small aneurysms will receive cyclosporine A orally, or a placebo (fake liquid), every day during a short period of time. Efficacy of the drug will be evaluated by measuring the diameter of the aneurysm during 2 years after treatment cessation. Drug safety analysis will evaluate the impact of the drug on renal function, blood pressure, and other parameters. In case of adverse event during the drug administration phase, dose of the drug or of the placebo will be decreased or administration stopped.

NCT ID: NCT02224794 Completed - Clinical trials for Abdominal Aortic Aneurysm

LIFE Study: Least Invasive Fast-Track EVAR

Start date: September 2014
Phase:
Study type: Observational [Patient Registry]

The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits associated with using the Ovation® Abdominal Stent Graft Platform 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.

NCT ID: NCT02182908 Completed - Clinical trials for Medically-treated Aneurysm of Abdominal Aorta

FDG PET-Scan Analysis of Evolutivity of Non-surgical Aneurysm of Abdominal Aorta

AAA
Start date: March 2007
Phase: N/A
Study type: Interventional

The primary aim of the study is to determine if the evolutivity of global and segmentary captation of FDG-F18, which can be measured in the wall of abdominal aorta aneurysm, is predictive of the 9 month evolution of diameter and volume of the aneurysm, measured globally and segmentary in angioscan.