Active clinical trials for "Constriction, Pathologic"

The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis

Aortic stenosis (AS) affects approximately 5% of individuals >65 years old, with ~3% of people >75 years having moderate to severe disease. The prevalence of AS is rising rapidly due to an ageing population and is projected to double in the next two decades. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms because the heart compensates for the AS. Ultimately, compensatory mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients with severe AS remain untreated, they have a dire prognosis. In this situation the only effective treatment is AVR, either surgically or using TAVI. Conversely, conventional teaching and clinical practice in cardiology has been that, in the absence of symptoms, the prognosis is usually excellent and, except in a few very specific circumstances, conservative management and regular review (expectant management) is recommended. This advice is reflected in current international guidelines but is based largely on historical precedent. There has never been a randomised controlled trial to address the relative benefits of early AVR versus expectant management in patients with severe asymptomatic AS. The relative benefits of a strategy of early AVR/TAVI versus expectant management in patients with asymptomatic severe AS are unclear. There is clinical equipoise but it remains one of the few areas of cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The EASY-AS study will provide crucial data on the relative merits of these differing approaches to management, in terms of important patient orientated outcomes, conventional cardiovascular end-points and cost effectiveness.

The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.

COPAS pilot is a pilot single center double blinded randomized study to determine the effect of targeted anti-inflammation therapy using colchicine, on valvular calcification activity using imaging, i.e. aortic valvular NaF uptake. The current proposal uses a randomized design to evaluate the effect of colchicine vs. placebo on valvular calcification activity over 6 months measured using NaF PET

The purpose of this study is to evaluate the effectiveness of digital health management for intervention on Chinese population with head and neck vascular stenosis.

This study is designed as a prospective comparative randomized clinical study to determine the diagnostic accuracy (sensitivity, specificity, positive predictive value, and negative predictive value) of pulsed fluoroscopy retrograde urethrogram for urethral stricture disease. The target population includes patients scheduled for retrograde urethrogram either new referral or follow up at Thunder Bay Regional Health Sciences Centre (TBRHSC) for treatment of urethral stricture who meet the specific eligibility criteria. The overall number of participants targeted will be 46. Upon presentation to the urology clinic or ambulatory care unit, the treating urologist/investigator will notify the patient of an opportunity to participate in the study. If the patient is interested, a research team member who is not directly involved in the patient care will be invited to discuss the study to the potential participant. The study team member will obtain a full-informed consent form the potential participant. Following informed consent, participants will be screened to ensure they meet the specific eligibility requirements of this study, through consultation with their medical records and the treating urologist. Randomization will be conducted in a 1:1 allocation ratio to either treatment arm: (1) the Pulsed fluoroscopy retrograde urethrogram, or (2) the Traditional retrograde urethrogram. Using an Excel sheet, the RAND function will give a random code. The random code is a figure ranging from 0.00000000 to 0.9999999999. A 0.5 cut-off code will be used, below which we will use the small blocks of 4 cells (4 rows of excel) and above which we will use the large blocks of 8 cells (8 rows of excel). Participants will undergo procedures according to the order of randomization Participants will undergo either Pulsed fluoroscopy retrograde urethrogram or Traditional retrograde urethrogram, depending on the treatment arm they are randomized to. Clinical data such as stricture location, stricture length and possible adverse effects will be recorded. According to the urologist decision based on data obtained during RUG, participant will be scheduled for urethroplasty or cystoscopy. All participants will undergo these procedures according to standard care procedures at TBRHSC. Data collection at baseline will include demographics, and relevant medical history. All retrograde urethrogram data including the type of urethrogram, the urethrogram date, fluoroscopy time, cumulative radiation dose, stricture location, stricture length and intraprocedural complications. Furthermore, we will record intraoperative data such as operative date, stricture location and stricture length. De-identified research files will be maintained in a secure office of a research team member during the conduct of the study. De-identified research data will be input into an electronic database that is password protected and maintained on research team member's computers or encrypted USB devices. An enrolment log, linking Participant ID to identifiable information will be maintained in hard copy in a locked office, or electronically as a password-protected document on the TBRHSC network. Only delegated research team members and the Principal Investigator will have access to research and patient data. Upon study closure, research records will be kept in secure storage in a research team member's office for a period of 5 years. Following this, the files will be securely shredded, and any electronic documents permanently deleted. Data will be analyzed using the commercially available SPSS software version 26 (SPSS Inc., Chicago, IL, USA). For both techniques, data obtained during baseline and postoperative urethrograms will be compared in terms of stricture location, stricture length, fluoroscopy time, cumulative radiation dose and the occurrence of intraprocedural complications. Categorical data will be compared using Chi-squared or Fisher test. Continuous data will be analyzed using the T test or Mann-Whitney U test Data obtained during urethroplasty will set as a standard of comparison to determine sensitivity, specificity, positive predictive value and negative predictive value of pulsed fluoroscopy and traditional urethrograms. For each comparison, 2 × 2 contingency tables were used to present the results and calculate the diagnostic accuracy estimates with 95% confidence intervals Data analysis will be done blindly regarding the type of performed procedure. One procedure will be coded as "1" and the other will "2". Categorical variables will be presented using number and percentage, and continuous variables will be presented using median and ranges. Two-tailed p-values of less than 0.05 will be set for statistical significance.

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality. The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR. TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.

Evaluate the lower indeterminate CBD strictures trying to reach possible diagnosis by all available methods i.e brush cytology ,bile aspirate cytology , tissue biopsy ,imaging studies and laboratory work up then treatment of the patient either endoscopically or surgically according to the etiology.

The presence of inducible myocardial ischemia is considered as the prerequisite for the clinical benefit of coronary revascularization. In this regard, the introduction of invasive pressure-derived physiological indices to guide myocardial revascularization represented a major breakthrough for the treatment of patients with coronary artery disease (CAD), by moving the focus of coronary revascularization from anatomy to physiology . The main premise of coronary physiology is to permit determination of the functional significance of individual stenoses on a per-vessel basis, measurable at the time of clinical decision-making process, thus providing an objective marker to identify ischemic lesions, and therefore patients, most likely to benefit from coronary revascularization . Fractional flow reserve (FFR) is the most widely used pressure-derived invasive physiological index for coronary lesion assessment in contemporary clinical practice. FFR is calculated as the ratio of the mean distal coronary pressure (Pd) to the mean proximal coronary pressure (Pa) across a stenosis during maximal hyperaemia, a condition that is commonly achieved by the intracoronary or intravenous administration of a potent vasodilator agent, such as adenosine. Based on the results of landmark clinical trials, most recent guidelines recommend the use of FFR to identify hemodynamically significant coronary lesions in patients with stable CAD. Despite this, the worldwide adoption of FFR into current clinical practice remains limited , accounting for only 9.8% of coronary procedures in Switzerland . Potential reasons for the low adoption rate of coronary physiology include technical challenges and time consumption related to FFR measurements, inadequate or lack of reimbursement, physician preferences, patient-related discomfort, contraindications and costs associated with adenosine, or in certain countries, no availability of adenosine. The low use of FFR in clinical practice provided a rationale for the development of new invasive physiology indices. By negating the need for administration of pharmacologic agents such as adenosine, saving time, and reducing costs and side effects, hyperaemia-free pressure-derived physiological indices were developed to increase adoption of physiology-guided coronary revascularization into routine clinical practice.

The trial will be conducted to evaluate the safety and efficacy of the BeGraft Peripheral Stent Graft System in interventional revascularisation for subjects with primary iliac artery stenosis and/or occlusive lesions by conducting a multi-centre, randomised controlled clinical study with a bare metal stent system as the control, thus providing a basis for the formal use of the product in China