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Aortic Aneurysm clinical trials

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NCT ID: NCT04299984 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

Italian Multicenter Database for Open Conversions After EVAR

iConveRt
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC). LOC is defined as a total or partial endograft explantation >30 days after the initial EVAR. SC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation. The aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.

NCT ID: NCT04252079 Not yet recruiting - Clinical trials for Juxtarenal Aortic Aneurysm

Endovascular Repair of Juxtarenal Aortic Aneurysm

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The investigators compare different endovascular techniques as an alternative to surgical reconstruction to repair JAAS regarding ; success rates, 30-day mortality,endoleak events secondary intervention rates

NCT ID: NCT04224675 Not yet recruiting - Aneurysm Clinical Trials

Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms

Start date: March 7, 2020
Phase: N/A
Study type: Interventional

Thoracic aortic aneurysms (TAA) are considered "silent killers" because they scarcely display any symptomatology, but are correlated with significant mortality and morbidity. Current guidelines regard aortic aneurysm disease as a coronary artery disease equivalent and suggest aspirin and statin use to reduce the progression of atherosclerosis, as well as beta-blocker (BB) therapy. No therapy, however, is effective at limiting aneurysm expansion and preventing rupture, even in large trials. TAA has emerged as an inflammation-mediated disorder. Angiotensin-converting enzyme inhibitors (ACEIs) can reduce the wall shear stress and inflammation, both of which play vital roles in the expansion of the aneurysm. The study will be a randomized, double-blind trial. Patients will be randomized into one of two parallel arms, receiving captopril or atenolol. The doses of captopril and atenolol will be 25 mg daily for the first 15 days, rising to 100 mg according to clinical tolerance and BP estimates. The sample size will be set at 424 subjects (212 per group). The primary end-point will be the rate of change in the absolute diameter of the aortic root and ascending aorta on MRI of the aorta after 36 months of therapy with captopril vs. atenolol. BBs have not been precisely found to decrease aneurysm growth rates. ACEIs could lead to the prevention of aneurysm degeneration through their antihypertensive and anti-inflammatory properties. The results of this trial will clarify that ACEIs are superior to BB therapy in reducing the growth rate of TAAs, the rate of change in aortic insufficiency, the time to aortic rupture or dissection, the need for aortic surgery or intervention, and death.

NCT ID: NCT04089241 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair

Start date: September 2020
Phase: N/A
Study type: Interventional

Abdominal Aortic Aneurysm (AAA) is a known vascular entity that may be life threatening condition .The most common treatment approach nowadays is the endovascular approach, a procedure known as endovascular aortic repair (EVAR). The most common procedure related complication is the expansion of the aneurysm from a "feeding vessel", usually a lumbar or intercostal artery. Another known complication is an endoleak from the stentgraft.Today, accepted EVAR follow up protocol consists of one multiple multiphasic CT angiography (CTA) scan, one month after the procedure and ultrasound exams there after . Ultrasonography is a useful method for detection and evaluation of AAA, has no ionizing radiation and is useful for the dynamic estimation of the aortic width in patients post EVAR. However, the sensitivity of ultrasonography solely for detection of endoleaks in post EVAR patients is not high.In recent years, the development of "fusion" applications allows the dual modality merge between ultrasound and CT scans that can be used as follow up examinations of known imaging findings on CT .Another application that had been developed for ultrasound machines is the ability to generate a 3 dimensional (3D) reconstruction which allows more precision. In the recent year the usage of intravenous contrast agent for ultrasonography based on microbubbles (BRACO SONOVIEW) has been approved by the Israeli ministry of health. This contrast agent is not nephrotoxic and the risk for allergic reaction is very low statistically similar to Gadolinium.A 3D contrast enhanced ultrasonography "fused" together with CTA may be a helpfull addition , which lacks radiation and odine contrast reactions and nephrotoxicity ,in the follow up in post EVAR patients , by means of identifing endoleaks at an earlier stage than by ultrasound alone. The purpose of our research is to evaluate the combined modality (fusion of CTA with CEUS) mentioned above in identifing early endoleaks in post EVAR patients and thus enabilng early intervention when needed

NCT ID: NCT03499431 Not yet recruiting - Aortic Aneurysm Clinical Trials

Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms

LoRETA
Start date: April 30, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the long-term safety and performance of complex endovascular aneurysm repair by inclusion in a longitudinal registry

NCT ID: NCT03365050 Not yet recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

A Study of the Safety of Targeted AAA Screening

Start date: December 1, 2021
Phase:
Study type: Observational

This study is a data linkage project within which we aim to model the impact on the NHS AAA Screening programme of a targeted approach to screening by targeting men who smoke. This in-silico study will generate a hypothetical population based on primary care datasets with known outcomes from screening (we know which men have an aneurysm and who do not) to determine the feasibility and safety of this approach.

NCT ID: NCT03267875 Not yet recruiting - Aortic Aneurysm Clinical Trials

A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of recently discovered medical conditions. The properties that bind them are: lesions similar to tumors in the mixed organs, lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and often, but not always, a high level of IgG4 in the serum. This disease has been on the rise for the past two decades and since its recognition in 2001 there has been impressive progress in understanding its various manifestations, so that today almost every body system can be involved. One of the conditions associated with this disease is oritis / periortitis and aneurysms

NCT ID: NCT02997618 Not yet recruiting - Clinical trials for Aortic Aneurysm, Abdominal

The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise in Patients With Abdominal Aortic Aneurysms

Start date: November 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02888613 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysms

Mini-laparotomy Versus Mini Lumbotomy

RAMini
Start date: September 2018
Phase: N/A
Study type: Interventional

This study aims to compare the results of two mini invasive surgical approaches in abdominal aortic surgery: mini lumbotomy with retroperitoneal approach versus mini laparotomy with transperitoneal approach. Respiratory and renal functions and recovery of intestinal transit will be assessed after 30 days. The secondary purpose of this study is to assess the life quality and morbi-mortality at 30 days, as well as at 6 and 12 months.

NCT ID: NCT02843854 Not yet recruiting - Clinical trials for Peripheral Artery Disease

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

VIVAAA
Start date: October 2016
Phase: Phase 1
Study type: Interventional

This study will assess the safety and efficacy of systemic (IV) administration of escalating doses of allogeneic MSCs in modulating immune cell phenotypes and suppressing aortic inflammation in patients with small AAA. Subjects will be randomized in a 1:1:1 fashion to receive mesenchymal stromal cells (1 million or 3 million MSC/kg) intra-venously or placebo (Plasmalyte A).