Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 440 trials
NCT07548099
This research study is being conducted to test how an imaging drug called 64Cu-DOTA-ECL1i can be used to image an abdominal aortic aneurysm. 64Cu-DOTA-ECL1i is a drug used with an imaging test called a PET/CT (Positron Emission Tomography/Computed Tomography). The aim is to collect data using a new imaging drug called 64Cu-DOTA-ECL1i that may be able to create images of inflammation in the aorta, which is thought to be important in how aneurysms grow and develop and to understand how consistent these scans are across time and what might affect the inflammation.
NCT06872684
The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.
NCT07518251
The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 236 participants diagnosed with TAAA from 4 hospitals in China. All patients receive TAAAR procedure and are randomized to control group (LHB) and experimental group (fCPB) in the ratio of 1:1. After a 1-year follow-up, the validity and safety of the different cardiopulmonary bypass for TAAAR is evaluated via the incidence of major adverse events including surgical mortality, RRT, stroke, and SCI, as well as intraoperative blood product transfusion volume, mechanical ventilation, and early mortality.
NCT06866210
Intracranial aneurysms (IA) are arterial malformations affecting about 3% of the overall population. Rupture is the most severe complication, as it is associated with nearly 30% of death or severe disability. The available scores to assess rupture risk are mainly based on usual modifiable and non-modifiable risk factors from the literature, but they appear insufficient to predict rupture. Emerging factors, such as sleep apnea syndrome and the use of certain medications, seem to influence the risk of rupture. The study of social determinants of health (SDOH) is highly relevant, given numerous reports showing the impact of SDOH, in addition to vascular risk factors, on vascular diseases like ischemic stroke or myocardial infarction. It is therefore reasonable to study the interaction between rupture risk factors and SDOH on the rupture risk of IA. Several initiatives have been undertaken to assess rupture risk, but few have included SDH. Limitations were often raised, especially regarding data accessibility. However, it is now possible, thanks to artificial intelligence (AI) algorithms, particularly natural language processing (NLP), to reuse large-scale health data to address longstanding issues, such as those posed by SDH. The use of health data warehouses (HDWs) offers an opportunity to collect and analyze accurate, real-world data, particularly through AI and NLP to extract information from medical reports. However, various challenges limit the use of NLP models, notably the dominance of models trained on English medical texts and privacy-related legislative restrictions. Therefore, alongside leveraging these models for clinical research, it is essential to continue efforts to develop transparent French-language models that comply with legislation. Thus, the ARAMISS project proposes to study the interaction between SDH and known risk factors for IA rupture by comparing control populations and rupture cases. This study will be based on a certified health data warehouse (HDW) and an NLP algorithm previously developed by the team. In parallel, the project plans two FAIR-compliant knowledge-sharing approaches to disseminate the algorithm and training corpus to the broader community.
NCT07499206
This study aims to assess a simple intervention: Visualization of lymphatic injury + treatment (in case of detection). This will generate data on the incidence of intraoperative lymphatic injury and the effect of treatment. This data will then hopefully enable a multi-center RCT to generate high level evidence on this matter.
NCT07480395
The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion
NCT07473102
A first-in-human evaluation of \[64Cu\]-RYM2 with PET/CT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).
NCT07474935
TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC variants (Hydrophilic Polymer Coating) where applicable as well as coil systems, and other adjunctive medical devices. The overarching purpose of this registry is to carry out a proactive gathering, recording, and analysis of data on the safety, performance and usability of the devices as applied within the routine practice of the participating registry sites.
NCT04246463
Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.
NCT07441564
Juxta-renal abdominal aortic aneurysms (AAA) are challenging to treat with standard endovascular techniques (EVAR) due to their proximity to the renal arteries. Open surgical repair continues to be used in patients unsuitable for EVAR but carries a high risk of acute kidney injury (AKI), up to 24%. Postoperative AKI is a strong predictor of both short- and long-term cardiovascular mortality. The KDIGO criteria are used to better define and stage AKI. Pharmacological prevention strategies have shown limited effectiveness, prompting interest in ischemic preconditioning (IPC). Remote IPC has shown mixed results in cardiac and vascular surgery, depending on patient risk and protocols used. Local IPC, applied directly near the renal arteries, has shown promising renal protection in animal models. However, this technique has never been clinically tested in humans. We propose here a randomized trial to assess the efficacy of local IPC before suprarenal aortic clamping during open repair of juxta-renal AAA to reduce postoperative AKI.
NCT07438275
This prospective observational study aims to evaluate the effectiveness of Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) monitoring during endovascular coil embolization of cerebral aneurysms under general anesthesia. Changes in regional cerebral oxygen saturation (rSO₂) measured by NIRS will be assessed in relation to BIS values and hemodynamic parameters throughout the procedure. The frequency, duration, and severity of cerebral desaturation episodes detected by NIRS, as well as their association with anesthetic depth and hemodynamic fluctuations, will be analyzed. The study does not involve any additional intervention beyond routine clinical monitoring.
NCT03446287
This is a prospective, non-randomized, single center, data collection study of patients treated with open surgical repair (OR) for complex aortic aneurysms (CAAs).
NCT04875429
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
NCT07422129
Surgical indication in patients suffering from Ascending aorta aneurysm is currently based mainly on the maximum diameter of the aortic dilatation and on the yearly growth rate. Several clinical preoperative patients characteristics have been, potentially, correlated to impaired mechanical characteristics of aortic wall, and therefore to an increased risk of rupture and or dissection. On other hands, such suppositions have been never confirmed, as a full characterization of the mechanical behaviour of the ascending aortic tissue, especially in case of aneurysm, has not been fully clarified yet. Objective of this observational study is to better elucidate, using direct in vivo evaluation, the mechanical characteristics of the aortic wall in patients with ascending aorta diseases. Our study will have a further peculiar characteristic as we have the intention of compare such mechanical characteristics to those of patients, without known aortic diseases, undergoing heart transplantation. Potential correlation between, directly measured mechanical characteristics of the aortic wall, and preoperative parameters (anagraphic patients characteristics, clinical data and diagnostic tests) will be also investigated.
NCT01524276
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
NCT05954793
The INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with thoracoabdominal aortic aneurysms.
NCT02692664
In this study, patients will be observed who receive an E-liac Stent Graft for treatment of isolated iliac aneurysms or an E-liac Stent Graft in combination with one of the following AAA stent grafts: E-tegra Stent Graft, Endurant AAA Stent Graft, Zenith AAA Endovascular Graft, Gore Excluder AAA Endoprosthesis for treatment of aorto-iliac aneurysms. Objectives of this post-market registry are: Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aorto-iliac or iliac aneurysm.
NCT06798740
The objective of this study is to verify the performance and safety of the Sugita Aneurysm Clips devices when used as intended and to identify possible risk factors. Data collected will be used to support the continuing performance and safety of the devices in the post-market use environment in Europe. Subjects who have an intracranial aneurysm that the physician intends to treat with the subject devices will be included in the study. Subjects will be followup as per hospital standard of care for 5 years.
NCT07078383
The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta. This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels. The first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in a planned surgery. After the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in an emergency setting. Data will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.
NCT06218875
A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.