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Aneurysm clinical trials

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NCT ID: NCT05576727 Not yet recruiting - Clinical trials for Intracranial Aneurysm

Prediction of Development and Rupture Risk for Intracranial Unruptured Aneurysms

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

In recent years, researches on the natural history and risk factors of intracranial unruptured aneurysms have become a hot topic at home and abroad. However, risk factors for aneurysm rupture is still unclear yet. The investigators' preliminary study focused on constructing a rupture risk prediction system for intracranial unruptured aneurysm in the investigators' single center. The investigators' result showed that three significant factors (sex, abnormal serum tumor necrosis factor (TNF)-α and coincidence of thin-walled regions (TWR) and normalized wall shear stress (NWSS)) stood out by using logistic regression to explore the rupture risk factors of intracranial unruptured aneurysms, which could help guide the clinical treatment of intracranial unruptured aneurysms. This study is to evaluate and improve the rupture predict model of intracranial unruptured aneurysm in multi-neurosurgical centers.

NCT ID: NCT05575570 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm Without Rupture

Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

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

Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study

NCT ID: NCT05531084 Not yet recruiting - Aortic Aneurysm Clinical Trials

Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms

Assets
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).

NCT ID: NCT05419661 Not yet recruiting - Aneurysm Cerebral Clinical Trials

Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms

Anev3D
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

It is now considered that 1% to 2% of the French population has an intracranial aneurysm. The major risk of this malformation is essentially the rupture which will lead in 10% of cases to death immediately, in 30% to 50% death within three weeks and in 30% of cases the patients will present a permanent disability. The management of this pathology represents today a major health challenge. Historically, neurosurgery was the discipline of first choice for the treatment of this pathology. This consists of clipping the aneurysm by a surgical approach to exclude it from the blood circulation and thus avoid its rupture. For many years now, interventional neuroradiology has established itself, through its "minimally invasive" and endovascular approach, as the reference treatment for ruptured and non-ruptured intracranial aneurysms: this is embolization. This so-called minimally invasive technique consists of placing directly into the aneurysm, using micro-catheters that are navigated under radiological control from the femoral artery, turns of plates called "coils" or prostheses called " stent" or "flow-diverter". This technique makes it possible to secure the aneurysm from the inside and thus reduce the risk of rupture. Today, 95% of patients are treated using this innovative technique and limited intraoperative risks. Interventional neuroradiology has constantly known in recent years a set of revolutions and innovations in terms of implantable medical devices (IMD) allowing to treat more and more patients with excellent clinical results. Today, the interventional neuroradiologist, assisted by the radiographer, has a very wide range of IMDs that he can combine with each other depending on the type, location, size and shape of the aneurysm. The role of the manipulator, here, is to work closely with the neuroradiologist so that he has, on the one hand, quality images and on the other hand, that he can count on a precious ally, an expert in IMDs, during embolization procedures. However, the wide choice of medical devices and the complexity of the aneurysms to be treated sometimes make treatment complicated. On the day of the "cold" treatment of the aneurysm (i.e. non-ruptured), the technicality of the catheterization and aneurysm's spatial conformation complicates the deployment of embolization equipment. This then sometimes leads to undesirable events such as intraoperative rupture. The very purpose of this study is to be able, by means of a 3D printer, to print the patient's aneurysm from the segmented 3D images obtained during the initial assessment and thus proceed to a simulation of the embolization procedure. This pre-operative planning (PPO) carried out in real conditions aims to anticipate the possible complications that could be encountered on the same day of treatment.

NCT ID: NCT05409118 Not yet recruiting - AAA Clinical Trials

JAGUAR Trial (Outside United States; OUS): ObJective Analysis to GaUge EVAR Outcomes Through Randomization

Start date: December 2024
Phase: N/A
Study type: Interventional

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).

NCT ID: NCT05399706 Not yet recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Sex-specific Differences in AAA Complexity

Start date: July 31, 2022
Phase:
Study type: Observational

A retrospective cohort study of computed tomography scans of AAA patients considered for repair, in order to identify sex specific differences in abdominal aortic aneurysm (AAA) metrics and the association between anatomical differences/features of complexity and adverse patient outcome.

NCT ID: NCT05395598 Not yet recruiting - Clinical trials for Thoracic Aortic Aneurysm

Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

MOTAAR
Start date: October 2022
Phase:
Study type: Observational

Thoracic aneurysm is a silent disease with a potential mid-term high risk of death or major complications. Few data are available on the real incidence of major complications in case of small and moderate thoracic aneurysm. Different factors are supposed to increase the risk of aortic enlargement as high blood pressure and sleep disorder breathing. The modality of imaging and clinical follow-up are well defined. In this prospective observational study, the aim to assess the incidence of of major complications during follow-up in a population of patients with a small or moderate thoracic aneurysm. The study will also try to identify systemic factors influencing aneurysm evolution.

NCT ID: NCT05361772 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial

COIN
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

COIN trial is a a prospective, randomized, placebo-controlled, double-blind, multicenter clinical study. Approximately 230 patients with small abdominal aortic aneurysms (AAA) will be randomly allocated to low-dose colchicine group or placebo group. All study patients will be followed up in the outpatient clinic every 3 months and undergo CTA scans after 24 months from randomization. The primary objective is to test the hypothesis that low dose colchicine can inhibit the progression of AAA diameter. The secondary objective is to test the hypothesis that low dose colchicine can inhibit the progression of AAA volume, reduce the incidence of clinical outcomes associated with AAA, reduce the incidence of major adverse cardiovascular events and all-cause mortality.

NCT ID: NCT05305378 Not yet recruiting - Clinical trials for Aneurysm, AVM, Dural Arteriovenous Fistula, Glioma, Meningioma, Metastasis, Bypass

Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow

Start date: April 15, 2022
Phase: N/A
Study type: Interventional

The purpose of the proposed study is to investigate the usefulness of laser speckle contrast imaging (LSCI) compared to indocyanine green angiography (ICGA). We will collect data from a wide variety of neurovascular surgical procedures to determine when the technology is the most clinically useful. The intraoperative LSCI system provides high resolution images of blood flow in real-time without tissue contact and without the need for an exogenous contrast agent. Further study is needed to gain a better understanding of the use of the technique during surgery, but initial results suggest that the ability to identify blood flow changes with immediate feedback to the surgeon could be a significant advantage during many procedures.

NCT ID: NCT05279274 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm Without Rupture

ShorT Stay Aneurysm Repair Study

STAR
Start date: November 1, 2022
Phase:
Study type: Observational

A prospective observational cohort study to assess the eligibility, uptake, viability, acceptability, safety, and cost of a ShorT stay (23-hour) Aneurysm Repair (STAR) pathway. Outcomes will be collected for up to 1 year.