21 results
The purpose of this study is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft System versus Gore Excluder/Excluder Conformable AAA Endoprosthesis in subjects with AAA.
The aim of this study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with an outpatient biopsy for histological confirmation, is a faster, safer, cheaper and therefore more cost-effective way to detect or…
The aim of this research is to decrease the number of involved margins, resulting in less adjuvant therapy and less local recurrences.
To understand the mechanism of action of OA for the treatment of de novo, severely calcified coronary lesions prior to stent placement using optical coherence tomography (OCT) and to assess stent expansion, based on OCT derived minimal stent area (…
This traditional feasibility study intends to inform a future pivotal trial in the following two ways. Firstly, it aims to evaluate the potential of neural health metrics triggered by FMS, to predict the implant recipient*s auditory performance -…
This study has been transitioned to CTIS with ID 2024-515883-30-00 check the CTIS register for the current data. The primary objective of this study is to prove noninferiority regarding safety and effectiveness of 30-45 day of DAPT followed by…
Demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is non-inferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low…
Evaluate the safety and efficacy of Medtronic Intrepid* TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of…
To compare the clinical and angiographic outcomes of a strategy of native vessel PCI with SVG PCI in patients with prior CABG presenting with SVG failure and a clinical indication for repeat revascularization, as determined by the local Heart Team.
The main objective of this trial is to determine whether reusable catheters are not less efficient as single use catheters, measured by symptomatic UTIs. Secondary objectives are adverse events like hospital admissions due to UTIs, urethral damage/…
To assess the short-term and long-term safety and efficacy of bilateral ultrasound renal sympathetic denervation (RDN) of the native kidneys in renal transplant patients with uncontrolled hypertension.
An Open-label Extension Study of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
To evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with IPF.
LANDMARK Trial is designed to compare safety and effectiveness of Meril*s Myval Transcatheter Heart Valve (THV) series vs. Contemporary Valves (Edwards* Sapien THV series and Medtronic*s Evolut THV series) in patients with severe symptomatic native…
The aim of this study is to evaluate the safety and efficacy of the esophageal partially covered SEMS. We will pay specific attention to recurrent dysphagia rates, migration rates and pain.
To determine whether CDT in high-risk PE relative to systemic thrombolysis is:- more effective and safer in terms of a reduction of the composite endpoint on all-cause mortality and adverse events defined as treatment failure, major&…
The objective of this trial is to confirm that there are no new safety and performance outcomes for participants receiving the Axonics SNM System INS Model 4101 for the treatment of OAB and FI. The only notable difference between the existing,…
The objective of the SEAL Early Feasibility Study (STUDY) is to provide proof of concept and initialclinical safety data for the Aortoseal Endostapling System for the fixation and seal of abdominal aorticaneurysms (AAA) endovascular grafts to the…
Primary objective:To evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.Secondary objective(s):The secondary objectives are to evaluate…
The primary objective of this study is to evaluate the efficacy of the AtMoves Knee System in the clinical diagnostic process of aseptic knee loosening in knee prostheses. This will be measured by the number of *failed outcomes* resulting from…
The general aim of this project is to determine the (cost-)effectiveness of footwear modification in addition to GP-led usual care, compared to GP-led usual care alone for patients with first MTP joint osteoarthritis (OA) at 6 months of follow-up…