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Aneurysm clinical trials

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NCT ID: NCT03138434 Terminated - Clinical trials for Abdominal Aortic Aneurysm

Advanced MRI in AAA

Start date: April 12, 2017
Phase:
Study type: Observational

This study aims to determine whether advanced MRI sequences can provide robust and clinically relevant information about abdominal aortic aneurysms (AAAs). The MRI sequences will study outcomes related to blood flow inside AAA, microvasculature of the AAA vessel wall and intraluminal thrombus inside AAA. Robustness of these MRI sequences will be determined with testing of feasibility and reproducibility. Clinical relevance will be assessed by studying the association between the primary outcomes and disease severity. Disease severity will be expressed by AAA diameter. It is our hypothesis that these parameters are significantly related to disease severity and may therefore be future markers of disease progression.

NCT ID: NCT03113383 Terminated - Clinical trials for Thoracoabdominal Aortic Aneurysm

Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

Start date: August 18, 2017
Phase: N/A
Study type: Interventional

The primary objective of the clinical investigation is to assess the use of the the Visceral Manifold Thoracoabdominal Aortic Aneurysms (VTAAA) stent graft system to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year).

NCT ID: NCT02982200 Terminated - Clinical trials for Intracranial Aneurysm

Medina Embolization Device In Neurovascular Aneurysm Study

MEDINA
Start date: December 15, 2016
Phase:
Study type: Observational

A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study conducted to assess the performance of the Medina Embolization Device when used in unruptured and ruptured intracranial aneurysms.

NCT ID: NCT02864940 Terminated - Clinical trials for Subarachnoid Hemorrhage

Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients

MASH
Start date: June 2016
Phase: N/A
Study type: Interventional

The study aim is to determine if periodic online cognitive exercises (Lumosity) improve memory function in ruptured cerebral aneurysm patients with disabling baseline memory deficits within the first 24 months after rupture. Half of the subjects will be randomized to use Lumosity-designed online cognitive exercises and half will serve as an active control group performing online crossword puzzles.

NCT ID: NCT02846883 Terminated - Clinical trials for Abdominal Aortic Aneurysm

Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms

VIVAAA
Start date: December 5, 2016
Phase: Phase 1
Study type: Interventional

This project is to determine the safety and explore the effectiveness of allogeneic (not cells of the participant but those of another human) mesenchymal stromal cells (MSCs) in decreasing inflammation and possible enlargement of the participants' abdominal aortic aneurysm. Participants will be selected as a possible subject because of an abdominal aortic aneurysm discovered on the ultrasound or computed tomographic ("CT") scan requested by the participants' doctor. The purpose of this study is to collect information that will be used to determine if MSCs can be used to decrease inflammation and possibly slow down enlargement of the participants' aneurysm. The investigators will also be collecting blood samples to study special inflammatory cells that cause aneurysms as well as asking participants to have a "PET" (positron emission tomography) scan that can measure inflammation directly in the participants' aneurysm.

NCT ID: NCT02784431 Terminated - Clinical trials for Intracranial Aneurysm

Pilot Study of the Contour Neurovascular SystemTM

Start date: July 2016
Phase:
Study type: Interventional

Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA)

NCT ID: NCT02767518 Terminated - Aortic Aneurysm Clinical Trials

Prehabilitation for Aortic Repair Patients

PREPARE
Start date: February 2016
Phase: N/A
Study type: Interventional

This is a 2-group study comparing the effect of a "prehabilitation" program to usual care on quality of life and clinical outcomes in patients undergoing elective repair of their thoracic aorta.

NCT ID: NCT02735720 Terminated - Clinical trials for Thoracic Aortic Aneurysm

The CardiOvascular Remodeling Following Endovascular Aortic Repair (CORE) Study

CORE
Start date: March 14, 2017
Phase:
Study type: Observational [Patient Registry]

The use of TEVAR is increasing rapidly and patients even in younger patients. However, current endografts are several orders of magnitude stiffer than the native aorta. Pre-clinical and clinical studies have reported acute aortic stiffening after TEVAR resulting in hypertension, elevated pulse pressure, cardiac remodeling, reduced coronary perfusion, and finally, heart failure. These effects are markedly profound in young patients, as their hearts and aortas are more compliant. Previous studies on adverse cardiovascular remodeling have important limitations, such as retrospective design, use of echocardiography (with low reproducibility and high operator-dependency), and mixed populations. A systematic assessment of the deleterious effects of TEVAR is still missing. The objective of this study is to perform a prospective, non-randomized controlled, study in which blood pressure, heart rate, ECG, echocardiography, CT, MRI, intra-luminal hemodynamic assessment, computational modeling and biomarkers are used to assess cardiovascular remodeling following TEVAR. This study targets patients with thoracic aortic aneurysms (TAA) or penetrating aortic ulcers (PAU) treated with TEVAR. A control group will consist of TAA and PAU subjects who do not require endovascular treatment. The specific aims of the study include: 1) Quantification of cardiovascular remodeling following TEVAR in TAA or PAU patients. 2) Validation of computational modeling of thoracic aortic hemodynamics following TEVAR using the above clinical measurements. Once validated, computational analyses will be performed to virtually assess the impact of more compliant endografts on cardiac and aortic hemodynamics. 3) Investigation of diagnostic accuracy of ECG, BNP, NT-pro-BNP and Troponin T, for cardiac remodeling compared to MRI, the reference method. This study will assess the impact of thoracic aortic stent grafts on the cardiovascular system through non-invasive measurements. Although there are no direct benefits for the enrolled subjects, future aortic patients might benefit from better patient management with improved aortic endograft designs and long-term outcomes.

NCT ID: NCT02607501 Terminated - Clinical trials for Intracranial Aneurysm

European eCLIPS™ Safety, Feasibility and Efficacy Study

EESIS
Start date: April 1, 2016
Phase: N/A
Study type: Interventional

An open label, prospective, multicentre, single-arm, post marketing study evaluating the safety, technical feasibility, and efficacy of the eCLIPs™ Family of Products for the treatment of bifurcation intracranial aneurysms.

NCT ID: NCT02538822 Terminated - Clinical trials for Aortic Aneurysm, Thoracic

Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging

Start date: October 6, 2014
Phase: N/A
Study type: Interventional

Aneurysms of the thoracic ascending aorta are a serious pathology which may threatens life by rupture or dissection. Their incidence is estimated at 10.4 per 100,000 people. At present, the only parameter for assessing the risk of complication is the maximum diameter of the aneurysm. The only way to avoid a complication is a surgical replacement of the aneurysmal aorta by a prosthetic tube. This procedure is performed by sternotomy and with extracorporeal circulation and its death rate ranges between 3% and 5%. Surgical repair is indicated when the diameter of the aneurysm exceeds 5.5 cm for degenerative atheromatous aneurysms or 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos syndrome). However, there are aneurysms with diameter greater than the surgical threshold which remain stable. Conversely, complications have been described for aneurysms less than 4.5 cm in diameter. The criterion of diameter appears therefore as inadequate to assess the risk of complication of an aneurysm of the ascending aorta.Multiple methods have been described in the literature. One of them relies on in vitro mechanical testing on healthy or aneurysmal tissue. Another method is the vivo analysis from imaging (CT, MRI or ultrasound). So far, no algorithm is robust enough for predicting the risk of complication better than the universally used criterion of diameter. The pathophysiology of these aneurysms has also been explored from histological studies. The investigators know that the microstructure of the aortic wall of an aneurysm is deteriorated with a degradation of elastin fibers and collagen that determine to a large extent its biomechanical behavior. Histological analysis appears inseparable from biomechanical analysis.