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Aneurysm clinical trials

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NCT ID: NCT04183426 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA

One-Two-Treat
Start date: June 12, 2020
Phase:
Study type: Observational

Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications, which are strongly linked to vascular health. In 2013, the SMART risk score was developed to calculate the risk of the patients for recurrent vascular events based on clinical characteristics. Recently, a novel, easy to perform, non-invasive test of endothelial function (the carotid artery reactivity (CAR) test), reflecting target organ damage, has been introduced. The CAR is a simple, quick (5-min), non-invasive test that uses ultrasound to examine the carotid artery in response to sympathetic stimulation by placing one hand in cold water. This test shows strong agreement with both coronary and aortic responses to sympathetic stimulation and predicted CV-events in patients with peripheral arterial disease. The aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of CV-events after elective AAA repair in comparison to the SMART risk score. Secondary objectives are to investigate the predictive capacity of arterial stiffness measurements and the post-operative CAR-test for development of CV-events and to evaluate health status scores to provide insight if these scores can support clinical decision making.

NCT ID: NCT04162483 Recruiting - Clinical trials for Intracranial Aneurysm

Safety and Performance of the Neuroform Atlas™ Stent System

ATLAS-FR
Start date: November 19, 2019
Phase:
Study type: Observational

The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.

NCT ID: NCT04155606 Recruiting - Clinical trials for Intracranial Aneurysm

Comprehensive Aneurysm Management Trial

CAM
Start date: January 15, 2020
Phase: N/A
Study type: Interventional

The uncertainty regarding the management of Unruptured Intracranial Aneurysms (UIAs) has not progressed in the last 30 years. The fundamental ethical basis for this study is that physicians should only offer a risky preventive treatment when it has been shown to be beneficial. Before that, such treatment should be offered as an RCT. The CAM trial offers a comprehensive framework, so that all patients confronted with the clinical dilemma can be offered participation. The prinicpal questions to be addressed are : 1. do patients with UIAs, considered for curative treatments, have a better long-term clinical outcome with active treatment or conservative management? 2. when patients are considered ineligible for conservative management, and surgical and endovascular management are both judged reasonable, do patients with UIAs have a better long-term clinical outcome with surgical or endovascular management? The primary hypothesis for patients allocated to at least 2 options, one of which is conservative management is: the 10 year combined neurological morbidity and mortality (mRS>2) will be reduced from 24% to 16% (beta 80%; alpha 0.048; sample size 961 patients (836 plus 15% losses to FU and cross-overs) with active treatment. This study is designed as a pragmatic, comprehensive way to address the unruptured aneurysm clinical dilemma, combining large simple RCTs whenever patients are judged eligible for more than one management option, or otherwise a registry of each option. All patients with one or more UIAs will be eligible for participation in either a registry or one of the trials. Patients will be followed for 10 years according to a standard of car follow-up schedule. The primary outcome is survival without neurological dependency (mRS<3) at 10 years. The secondary outcomes are: 1. the incidence of SAH during follow-up and related morbidity and mortality; 2. the morbidity and mortality related to endovascular or surgical treatment of the UIA at one year; 3. overall mortality at 1, 5 and 10 years; 4. overall morbidity (mRS>2) at 1, 5 and 10 years; 5. length of hospitalization; 6. discharge to location other than home

NCT ID: NCT04150653 Recruiting - Clinical trials for Abdominal Aortic Aneurysm Without Rupture

Non-invasive Aortic Aneurysm Tissue Characterization Using Wall Viscoelasticity

AAA multiphase
Start date: September 1, 2020
Phase:
Study type: Observational

Abdominal aortic aneurysm (AAA) is an abnormal dilatation of the aorta in the abdomen due to a wall weakening caused by atherosclerosis. While indications for a rupture intervention are based on AAA maximal diameter (MaxD) (5 cm), 23% of ruptured AAAs are less than 5 cm and in large AAAs, rupture rate could be lower than expected. We propose to expand and validate our vascular ultrasound elastography software to 3D. Strain maps generated from radiofrequency (RF) data acquired from 30 AAA patients with a matrix-array 3D probe will be registered to conventional CT (phase 1) and validated to a biomechanical for characterization of AAA wall, assessing vulnerability and influence of surrounding tissues (phase 2). At the end of the project, we will have analyzed 3D strain maps to improve patient selection before surgery.

NCT ID: NCT04149483 Recruiting - Clinical trials for Intracranial Aneurysm

Statin Treatment for UnruptureD Intracranial anEurysms Study

STUDIES
Start date: November 7, 2019
Phase: Phase 2
Study type: Interventional

This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral atorvastatin.

NCT ID: NCT04141020 Recruiting - Cerebral Aneurysm Clinical Trials

Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

Start date: October 27, 2021
Phase: Phase 2
Study type: Interventional

The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.

NCT ID: NCT04100499 Recruiting - Aortic Aneurysm Clinical Trials

Evaluation of Adjunctive EndoAnchors for EVAR and TEVAR

Start date: December 31, 2019
Phase:
Study type: Observational [Patient Registry]

EndoAnchors (Heli-FX device, Medtronic, Santa Rosa) have beed described to improve fixation (mimicking an open surgical anastomosis) during or after EVAR/TEVAR. The investigators want to describe the outcomes of all consecutive patients treated with this device (retrospective and prospective data - observational study)

NCT ID: NCT04057352 Recruiting - Clinical trials for Unruptured Wide-neck Aneurysms

Citadel Embolization Device Study

Start date: July 17, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms.

NCT ID: NCT04021901 Recruiting - Stricture Ureter Clinical Trials

A Study of Balloon Dilatation for the Treatment of Benign Ureteral Stricture

Start date: November 1, 2018
Phase:
Study type: Observational

This study is designed to treat benign ureteral stricture with balloon dilatation through prospective multicenter studies. It aims to indications, procedure standards, and therapeutic effects of balloon dilation, and provide further guidance for endoscopic treatment of benign ureteral stricture.

NCT ID: NCT04005976 Recruiting - Aortic Aneurysm Clinical Trials

Montalcino Aortic Consortium: Precision Medicine for Heritable Thoracic Aortic Disease

MAC:H-TAD
Start date: April 29, 2016
Phase:
Study type: Observational [Patient Registry]

The Montalcino Aortic Consortium (MAC) will provide the infrastructure to assemble large cohorts of patients with mutations in known heritable thoracic aortic disease (H-TAD) genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers of H-TAD.