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Aneurysm clinical trials

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NCT ID: NCT06349382 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

CArbohydrate Loading in Aortic Surgery

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The adverse effects of overnight fasting before surgery have been well-documented in the contemporary literature. Still, due to the possibility of pulmonary aspiration of gastric contents, many clinicians worldwide still employ this practice. On the other hand, the benefits of preoperative oral carbohydrate loading (OCHL) have been shown in various patient groups. Studies examining the usefulness of preoperative OCHL in aortic surgery are lacking. In particular, no randomized control trials have specifically examined the impact of preoperative OCHL on the postoperative course in patients undergoing open abdominal aortic surgery.

NCT ID: NCT06332911 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm Without Rupture

Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

TEVAR
Start date: August 1, 2024
Phase:
Study type: Observational

Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study. The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR.

NCT ID: NCT06325371 Not yet recruiting - Aneurysm Abdominal Clinical Trials

Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2

DEDICATE
Start date: April 1, 2024
Phase:
Study type: Observational

This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention. The enrollment period will be of 54 months (01/01/2020-30/06/2024). Minimum sample size will be of 50 Patients.

NCT ID: NCT06308952 Not yet recruiting - Clinical trials for Degree of In-stent Stenosis (as Measured by WASID Method) at the 12th ±1 Month Annual Angiographic Follow-up

Effectiveness of Atorvastatin in Preventing Cerebrovascular Events After Flow Diverter Implantation

Start date: July 5, 2024
Phase: Phase 4
Study type: Interventional

In recent years, with the development of medical technology and materials and instruments, flow diverter (FD) has gradually become the most important treatment method for the treatment of intracranial aneurysms (IA). It is a revolutionary treatment method, which has changed the concept of endovascular treatment of IA, and turned the previous endovascular embolization to the reconstruction of the parent artery. At present, FD has been used in more than 250,000 cases worldwide, and the overall 1-year complete occlusion rate of aneurysms can reach 75%-85.5%. However, although the current imaging prognosis of FD is encouraging, the perioperative complications of FD are as high as 12.9%, including ischemic complications, SAH, and parenchymal hemorrhage in 7.3%, 2.0%, and 2.0%, respectively. The postoperative mortality was 1.5%, of which 1.3% were caused by delayed aneurysm rupture, distal parenchymal hemorrhage and PED-related nerve compression symptoms. In addition, an in-stent stenosis of more than 50% within one year has been reported in 10.2 to 15.0% of patients. However, in addition to conventional dual antibody therapy, there is no relevant guideline recommendation or clinical evidence on how to prevent complications after FD implantation in IA patients. Atorvastatin is widely used in the primary and secondary prevention of cardiovascular and cerebrovascular diseases. Its main effect is to improve the incidence of cardiovascular and cerebrovascular events by reducing blood lipids. Although the mechanism of clinical benefit of lipid-lowering by atorvastatin is not completely clear, a large number of clinical evidence has shown that atorvastatin can also reverse atherosclerosis, stabilize plate, reduce inflammation, reverse vascular endothelial dysfunction and reduce microthrombosis. It can reduce the incidence of cardiovascular and cerebrovascular events in patients with coronary heart disease and internal carotid artery stenosis after stent implantation in different degrees. However, there is no high-quality clinical evidence for the use of atorvastatin in intracranial aneurysm stent implantation. Previous retrospective studies have shown that atorvastatin is the only protective factor for in-stent restenosis after flow diverter implantation in intracranial aneurysms. In a retrospective observational study involving 273 patients empirically treated with atorvastatin for unruptured IA in our center, the median follow-up period was 7.6 months. The incidence of cerebrovascular events was 3.27%, and the incidence of more than 50% in-stent stenosis was 8.4%, which was significantly lower than the incidence of related events reported at home and abroad. Therefore, this study planned to conduct a randomized controlled clinical trial to confirm the efficacy and safety of oral atorvastatin in the prevention of cerebrovascular adverse events after stent implantation in patients with unruptured intracranial aneurysms, and to provide objective evidence for the treatment decision of patients with unruptured intracranial aneurysms to prevent cerebrovascular adverse events after flow diverter implantation.

NCT ID: NCT06276413 Not yet recruiting - Aortic Dissection Clinical Trials

REgistRy BRAnch goRE EndopRosthEsis

REBRA
Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis

NCT ID: NCT06267573 Not yet recruiting - Clinical trials for Thoracoabdominal Aortic Aneurysm

Thoracoabdominal Aortic Aneurysms

Start date: September 2024
Phase:
Study type: Observational

Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA

NCT ID: NCT06256757 Not yet recruiting - Clinical trials for Aortic Dissection Aneurysm

Safety and Validity of Extracorporeal Fenestration and in Situ Fenestration in Patients With Aortic Disease Involving the Left Subclavian Artery

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.

NCT ID: NCT06249802 Not yet recruiting - Clinical trials for Intracranial Aneurysm

Beta-blockade in Unruptured Intracranial Aneurysm

BBLURAN
Start date: January 1, 2025
Phase: Phase 4
Study type: Interventional

Subarachnoid haemorrhage is a devastating type of stroke, with high mortality and morbidity rate. In approximately 85% of cases, it is caused by an intracranial aneurysm rupture. Majority of patients with diagnosed intracranial aneurysm are eligible for interventional treatment, however, some patients are managed conservatively. Currently, the only recommendations for patients with conservatively managed intracranial aneurysms, are routine imaging follow-ups and minimization of rupture risk factors. There are no medications proven to decrease risk of aneurysm rupture, that might be prescribed to such patients. In preliminary study the investigators found that patients with intracranial aneurysms who took β-blockers had significantly smaller aneurysm rupture rate and dome size, as well as more favorable hemodynamic parameters. No other antihypertensive drugs showed similar associations. Therefore, in this project the investigators aim to further analyze the impact of β-blocker intake on fate of intracranial aneurysm and find possible explanations for its protective role. The investigators aim to perform a randomised, double-blind, placebo-controlled clinical trial. One hundred patients with unruptured intracranial aneurysm, , qualified to conservative management will be enrolled. Two arms (50 patients each) will be receiving nebivolol or matching placebo. Treatment in each arm will last 12 months. The following examinations will be performed at baseline and at 6 and 12 months: clinical assessment, angio-MRI with vessel wall imaging, Doppler ultrasound to extract blood flow waveforms from Internal Carotid Artery, Vertebral Artery Middle Cerebral Artery, Anterior Cerebral Artery and Posterior Cerebral Artery, as well as blood samples. Based on the results the investigators will assess changes in aneurysm size and wall contrast enhancement. The investigators will also analyze levels of possible aneurysm growth biomarkers in peripheral blood. Additionally, the investigators will prepare three-dimensional models of the artery harbouring aneurysm and perform patient-specific computer modelling of blood flow through such artery to assess hemodynamic parameters of aneurysm dome. All obtained measurements will be compared at baseline and at 6 and 12 months. The investigators hypothesize that, in comparison to the placebo group, β-blocker therapy in patients with unruptured intracranial aneurysm will contribute to favorable changes in hemodynamic parameters of aneurysm dome, decrease wall degradation process and prevent from aneurysm growth.

NCT ID: NCT06235619 Not yet recruiting - Aneurysm Clinical Trials

Arch Size Study for Anatomical Variations

Start date: September 2024
Phase:
Study type: Observational

The aortic arch with a common origin of the innominate and left carotid artery (CILCA) prevalence in the general population is 13.6%. Its reputation as a benign anatomical variant has been ultimately shattered by further studies [3, 4, 8, 9] that identified the CILCA arch as a potential marker for thoracic aortic disease (TAD) The aim of this work is to report the CT anatomical characteristics of the aortic arch in subjects with or without aneurysms requiring treatment, in 5 major European cardiovascular centers.

NCT ID: NCT06162273 Not yet recruiting - Clinical trials for Aortic Aneurysm, Abdominal

An Exploratory Study of Iliac Artery Branch Stent for Internal Iliac Artery Reconstruction in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair

Start date: December 1, 2023
Phase:
Study type: Observational

The purpose of this study is to evaluate the efficacy and safety of IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company in the treatment of abdominal aortic aneurysm/iliac aneurysm reconstruction of internal iliac artery