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Aneurysm clinical trials

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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: NCT06320132 Recruiting - Clinical trials for Intracranial Hemorrhages

BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage)

BLANDISH
Start date: March 13, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to train a machine learning system based on data from patients affected by spontaneous Intracranial Hemorrage. The main question it aims to answer is whether there is a correlation between actual clinical pratice, reached outcomes and favorable or unfavorable predictive factors, and anamnesis. Participants will be treated as per standard clinical practice.

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: March 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: NCT06303063 Recruiting - Clinical trials for Intracranial Aneurysm

Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms

Start date: January 17, 2024
Phase: N/A
Study type: Interventional

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.

NCT ID: NCT06286540 Recruiting - Clinical trials for Aorta Thoracic; Aneurysm

Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair.

Start date: February 22, 2023
Phase: N/A
Study type: Interventional

Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data.

NCT ID: NCT06286358 Recruiting - Clinical trials for Aortic Valve Disease

Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)

ARTIK
Start date: March 7, 2024
Phase:
Study type: Observational

Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface. The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable us to diagnose aortic valve disease and aortic aneurysm. In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging and KCG recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG.

NCT ID: NCT06282939 Recruiting - Clinical trials for Intracranial Aneurysm

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

OPTIMA
Start date: November 1, 2023
Phase:
Study type: Observational [Patient Registry]

This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System. The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures.

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.