
Extra Alirocumab in Addition to Statin Therapy in Asymptomatic Intracranial Atherosclerotic Stenosis...
Intracranial AtherosclerosisAtherosclerotic Plaque1 moreThe primary goal of the trial is to investigate whether the lipid lowering strategy using Alirocumab plus statin could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up, in patients with asymptomatic intracranial artery stenosis.

Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis
Lumbar Spinal StenosisLumbar spinal stenosis, a common condition in older adults, can cause pain and difficulty walking (i.e., intermittent neurogenic claudication - INC). Patients with INC not infrequently undergo spinal surgery that fails to help them 1/3-1/2 the time. The purpose of this multi-site feasibility study is to prepare for the conduct of a randomized controlled trial to test the efficacy of manual therapy, exercise, and intramuscular electroacupuncture in reducing pain and improving walking ability for those with INC, and ultimately limiting the need for surgical referrals.

Revascularization Effect on CSVD Burden in Carotid Artery Stenosis
Carotid Artery StenosisCerebral Small Vessel DiseasesRECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the progression of Cerebral small vessel disease (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral carotid artery and sign informed consent will be recruited. In this study, patients will be asked to undergo Computed Tomography Angiography (CTA)/ Digital Subtraction Angiography (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI), Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated follow-up can be up to 10 years.

Extra Alirocumab in Addition to Statin Therapy in Symptomatic IntraCranial Atherosclerotic Stenosis...
StrokeIntracranial Atherosclerotic StenosisThe primary goal of the trial is to investigate whether the lipid lowering strategy using Alirocumab plus statin could cause more changes from baseline in intracranial atherosclerotic plaque and hemodynamic features during 6 months of follow-up, in patients with recent stroke/transient ischemic attack (TIA) caused by intracranial artery stenosis.

The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme
Aortic StenosisThe goal of this observational study is to understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement. Participants will undergo transthoracic echocardiography every 6 months, with annual visits for state-of-the-art scanning techniques including positron-emission tomography combined with computed tomography or magnetic resonance imaging with radiotracers designed to look at disease processes including fibrosis, calcification, inflammation and thrombosis activity.

Safety and Potential Effect of Innovative Treatment by Adjuvant Injection of Stromal Vascular Fraction...
Urethral StenosisSURF is a randomised controlled, parallel group, single blind phase II study designed to assess the safety and potential efficacy of an innovative therapeutic strategy for urethral stenosis based on adjuvant injection of autologous Adipose-Derived Stromal Vascular Fraction of Adipose Tissue (ADSVF) during endoscopic urethrotomy (standard care).

Balloon-expandable vs Self-Expanding Transcatheter Heart Valve
Aortic Valve StenosisOver the last years, several randomized studies comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) have established TAVI as a treatment option in symptomatic patients with aortic stenosis (AS) (1,2,3). Most transcatheter heart valves (THV) available are designed on either a balloon-expandable (BE) or a self-expanding (SE) concept. Despite major differences, both designs are recommended to be used indifferently in most of the clinical situations and a significant number of centers only implant one of this two THV design. It remains unclear however, whether these 2 very different THV concepts are achieving similar or different clinical outcomes and could be considered a single "Class" of device. While there is an urgent clinical need to clarify this issue in an exponentially growing therapeutic field, to date no large randomized study powered to compare the 2 THV designs on individual endpoints has been conducted or initiated. Recently, two large-scale French registry-based propensity matched analyses, including more than 30,000 patients, have reported a higher 90 days and 1-year mortality with the use of SE as compared to BE-valve (4,5). However, as the propensity-score matching-approach cannot rule out residual confounders, and as some of the most recent THV iterations were not part of the investigation, there is an urgent need to conduct a randomized trial sufficiently powered to compare head-to-head the latest generation of SE and BE-valve on all-cause mortality. In addition, two small randomized studies have recently showed the inferiority of a new SE-valve compared to BE-valve and SE-THV (SCOPE1 trial, J Lanz. Lancet. 2019 Nov 2;394(10209):1619-1628. and SCOPE 2 trial, Circulation in press), thus further questioning wether THV should be considered as a single "Class" regardless the THV design. The objective of the present randomized clinical investigation will be to evaluate the impact of THV design (SE vs BE) on the risk of all-cause mortality at 90 days and 1 year. The present clinical investigation will the first randomized clinical investigation to compare head to head the benefit of BE-valve over SE-valve on total mortality at 90 days and 1-year using a superiority design. Previous head-to-head studies included only a small number of patients, non-inferiority designs and combined endpoints. This clinical investigation will be the first to generate sufficient evidences to change clinical practice and international guidelines to clarify whether one THV design is superior (or not) to the other one (BE vs SE-valve). The result of the clinical investigation is key for clinicians indicating the treatment and for the patients receiving the treatment

Covered Metal Ureteral Stents in the Treatment of Benign Short Ureteral Stricture
Ureteral StenosisBSUS patients were prospectively enrolled in this study, and non-randomly treated with "balloon dilation +CMUS" and "balloon dilation + tandem DJ stent". Perioperative data of the patients were recorded to compare their efficacy and complications, and the ureteral stent symptom questionnaire was used to compare their impact on patients' quality of life. CMUS and tandem DJ stents were removed after ≥3 months of indwelling. After the removal of stents, the patients' serum creatinine and renal pelvis width were followed up to compare their curative effect on BSUS.

Optilume Registry for Treatment of Stricture of the Anterior Urethra
Anterior Urethral StrictureMaleThe purpose of this registry is verifying the continued safety and effectiveness of the Optilume DCB clinical use in patients undergoing dilation of the urethral stricture.

Effect of Muscle Fatigue on Spinal Imbalance and Motion in Lumbar Spinal Stenosis
Lumbar Spinal StenosisThis study assesses spinal imbalance and motion in patients with sLSS and elicits fatigue via back exercises and compares spinal imbalance and motion before and after the fatigue exercise and compares these to healthy controls, allowing to associate sLSS-specific motion patterns to paraspinal muscle fatigue.