View clinical trials related to Constriction, Pathologic.
Filter by:The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.
Trial Title: Prospective, multicenter, single-arm target value clinical trial to evaluate the safety and efficacy of a transcatheter aortic valve system in the treatment of patients with severe aortic stenosis Test device: Transcatheter aortic valve system. Pilot Phase: Clinical Validation of Class III Medical Devices. Study design: prospective, multicenter, single-group target value. Sample size: 120 cases. Intended Use: The Transcatheter Aortic Valve System is indicated for patients with a diagnosis of severe aortic stenosis by the Comprehensive Heart Team. Objective: This clinical trial is a prospective, multicenter, single-arm study to evaluate the safety and efficacy of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis. Primary endpoint: 12-month postoperative all-cause mortality All-cause deaths include cardiac death and non-cardiac death. Secondary Endpoints: 1. Device success rate 2. Procedural success rate 3. Delivery system performance 4. Retrieval system performance (e.g. using a recycling system) 5. Exchange system performance 6. Valvular function at Immediately postoperative, 7 days/at discharge, 30 days, 6 months, 12 months, 2-5 years follow-up: valve stenosis, regurgitation, valve function (e.g., opening area, pressure gradient), paravalvular leakage 7. Improvement in quality of life at 30 days, 6 months, 12 months postoperatively 8. Improvement in cardiac function at 7 days/at discharge, 30 days, 6 months, 12 months, 2-5 years postoperatively Experimental design: This trial is a prospective, multicenter, single-group clinical study with a target value to evaluate the Transcatheter Aortic Valve system Safety and efficacy in the treatment of patients with severe aortic stenosis with 12 months of All-cause mortality after transcatheter aortic valve implantation. The mortality rate was the primary study endpoint, and after statistical assumptions and sample size calculations, 120 patients were planned to be enrolled. Patients were clinically followed immediately after valve implantation, 7 days postoperatively/at discharge, 30 days, 6 months, 12 months, and 2-5 years postoperatively. In this trial, all relevant clinical data were collected, sorted out and statistically analyzed by an independent data management and statistics center and a clinical monitoring institution. All enrolled subjects underwent outpatient follow-up at 30 days, 6 months, and 12 months after surgery, and performed relevant imaging examinations (ultrasound, etc.) and laboratory tests and safety evaluations, and continuous follow-up and cardiac ultrasound examinations were performed annually at 2-5 years to observe the occurrence of adverse events to evaluate the long-term safety of the transcatheter aortic valve system. The safety and efficacy of the transcatheter aortic valve system were evaluated with the subject's 12-month postoperative all-cause mortality as the primary endpoint, and the immediate postoperative device success rate, procedural success, retrieval system performance, valve function, cardiac function improvement, quality of life improvement, all-cause mortality in different follow-up periods, major adverse cardiovascular and cerebrovascular events, myocardial infarction, stroke, hemorrhage, acute kidney injury, permanent pacemaker implantation, serious vascular complications, and other TAVR-related complications were taken as the secondary endpoints to assist in evaluating the safety and efficacy of the test product, and to provide a basis for the final official listing and domestic marketing.
Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.
The dual pathology of aortic stenosis (AS) and cardiac amyloidosis (CA) is increasingly recognized. Even tough efforts have been undertaken to bring cohorts together, the largest cohort of AS-ATTR to date is <50 patients. It is the aim of the present international, multi-center registry to collect ~300 patients with AS-CA creating a big enough cohort to allow 1. thorough characterization of this condition 2. assessment of log-term clinical outcomes of AS-CA 3. assessment of effectiveness of amyloid-specific treatment on top of valve replacement
The purpose of this study is to explore the efficacy and safety of endoscopic scissors cutting nasobiliary ducts in the treatment of malignant hilar biliary tract stenosis
The clinical trial aims to evaluate the efficacy and safety of acupuncture in alleviating neurogenic claudication symptoms among patients with degenerative lumbar spinal stenosis (LSS).
Background: Large vessel carotid stenosis represent significant cause of ischaemic stroke. Indication for surgical revascularisation treatment relies on severity stenosis and clinical symptoms. Mild clinical symptoms such as transient ischemic attack, amaurosis fugax or minor stroke preceded large strokes in only 15% of cases. Aim: The aim of this prospective study is to evaluate whether retinal perfusion is impacted in significant carotid stenosis. Automated retinal oximetry could be used to better evaluate perfusion in post-stenotic basin. The investigators presume the more stenotic blood vessel, the more reduced retinal perfusion is resulting in adaptive changes such as higher arteriovenous saturation difference due to greater oxygen extraction. This could help broaden the indication spectrum for revascularisation treatment for carotid stenosis. Methods: The investigators plan to enroll 50 patients a year with significant carotid stenosis and cross-examine them with retinal oximetry. Study group will provide both stenotic vessels and non-stenotic vessels forming the control group. Patients with significant carotid stenosis will undergo an MRI examination to determine the presence of asymptomatic recent ischaemic lesions in the stenotic basin, and the correlation to oximetry parameters. Statistics: Correlation between the severity of stenosis and retinal oximetry parameters will be compared to the control group of non-stenotic sides with threshold of 70%, respectively 80% and 90% stenosis. Data will be statistically evaluated at the 5% level of statistical significance. Results will be then reevaluated with emphasis on MRI findings in the carotid basin. Conclusion: This prospective case control study protocol wil be used to launch a trial assessing the relationship between significant carotid stenosis and retinal perfusion measured via automated retinal oximetry.
This is a clinical evaluation to assess the effectiveness of cryospray therapy used in addition to current standard of care endoscopic therapies in preventing short term recurrent airway stenosis with a multicentric outcome evaluation. The investigators hypothesize that the addition of SCT to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence at 6 months as estimated by quantitative radiologic assessment of the stenotic volume.
This retrospective studed included patients referred to our institution between December 2013 and december 2021 for septoplasty or septorhinoplasty. All patients underwent pre operatory paranasal sinus CT scan and olfactory test. Olfacory cleft stenosis will be quoted as none (less than 1/3 contact between nasal septum and ethmoïd turbinates), partial (1/3-2/3 contact between nasal septum and turbinates) or total (more than 2/3 contact between nasal septum and turbinates), as well as Olfactory Cleft obstruction as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).
Lumbar spinal stenosis (LSS) is one of the most common degenerative diseases of the spinal column, with symptoms including low back pain which worsens with ambulation, poor balance, decreased activity due to pain, and a marked decrease in quality of life (QoL). Prevalence rises with age, and current treatment options range from varied conservative management strategies, to surgical intervention with decompression of neural structures. While the effects of surgical decompression on back pain and QoL has been widely researched, the effects of surgery on patient balance is less well understood. Though patients generally have subjective improvements in this parameter after surgery, objective measurements in this patient group have been lacking. This study aims to investigate the effects of decompressive surgery on postural balance in elderly patients with LSS. Measurements of postural balance will be taken before and after decompressive surgery, as well as with regular intervals during a two-year follow-up period. A better understanding of the effect that LSS has on balance may lead to more patients being able to receive surgical treatment, which is hypothesized to lead to an increase in QoL and less perceived disability amongst this patient group.