Active clinical trials for "Constriction, Pathologic"

Device: EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length) Objectives: To further assess the safety and efficacy of the small diameter (2.25 mm) Ridaforolimus Eluting Stent - EluNIR. Subject Population: Subjects who underwent PCI for angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, and recent STEMI (>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent. Trial Design and Methods: This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up for all patients will be performed at 30 days 6 months, and 1 year after the procedure.

This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders under study. The blood tests involve analysis for von Willebrand Factor antigen and activity, von Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The results of the blood tests will be compared to the information from the clinically-indicated echocardiogram and one blood test compared to another.

The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.

The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of FFRCT for myocardial ischemia were calculated per-patient level and per-vessel level with invasive FFR value as gold standard.

Pulmonary artery sling is a rare congenital pulmonary vascular malformation, often associated with tracheal or bronchial stenosis. Surgical treatment of pulmonary artery sling with tracheal stenosis has a high risk and a relatively poor prognosis. This article aims to explore the relationship between the index of tracheal and left pulmonary artery stenosis and the surgical effect of pulmonary artery sling with tracheal stenosis. Methods: Retrospective analysis of the cases of pulmonary artery sling surgery in our center from January 2010 to December 2018. Before operation, routine cardiac enhancement CT examination was performed, and the diameter of the left pulmonary artery and the tracheal stenosis were measured on the CT tomogram respectively, and the ratio of the degree of tracheal stenosis / left pulmonary artery stenosis (T / P) was calculated, combining the surgical method and clinical prognosis analyzed and discussed.

This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.

This study evaluates whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during cervical transforaminal epidural steroid injection

This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve replacement surgery (TAVR).

Background and Project Rationale: Degenerative aortic valve stenosis affects 2% of the elderly population aged 70 years or older and progresses insidiously with advancing age [1] before manifesting with symptoms such as decreased exercise tolerance, shortness of breath, chest pain and syncope on exertion. Without aortic valve replacement, the survival prognosis of patients with symptomatic aortic stenosis is poor. In the PARTNER 1B trial, all-cause mortality among 179 inoperable patients with severe symptomatic aortic stenosis allocated to conservative management amounted to 51% at one year [2]. Consistently, prospective registry data reported a mortality rate of 55% at 1 year in 78 patients with severe aortic stenosis undergoing conservative management [3]. The rapid spread of the SARS-CoV-2 pandemic represents an unprecedented challenge for healthcare systems. A limited number of ventilators and ICU beds call for a careful allocation of healthcare resources. On March 20 2020, the Federal Council prohibited elective interventions in all hospitals in Switzerland. Patients with untreated severe aortic stenosis are particularly vulnerable to SARS-CoV-2 infection [4] and face the dual risk of cardiac death from aortic stenosis on one side, and death from acute respiratory distress syndrome secondary to SARS-CoV-2 infection on the other. While the balance between the two risks is a matter of clinical judgement, the investigators established an algorithm for the management of patients with severe aortic stenosis during the SARS-CoV-2 pandemic. Patients with aortic stenosis deemed critical will undergo valvular replacement in spite of the ongoing pandemic while patients with severe but not critical aortic stenosis will undergo deferred intervention once the number of new SARS-CoV-2 infections flattens. In the current situation, aortic valve replacement in patients with severe, non-critical aortic stenosis will be deferred in order to give priority to SARS-CoV-2 patients. This unique situation allows the investigators to study the effect of deferral of aortic valve replacement in patients with severe aortic stenosis. The study is an amendment to the Swiss-TAVI registry. In contrast to the Swiss-TAVI registry, patients are not enrolled at the time of aortic valve replacement, but already at the time of referral for aortic valve replacement. Primary Objective: The aim of the present observational study is to explore the effect of deferral of valvular replacement in patients with severe but not critical aortic stenosis on morbidity and mortality. The primary objective is to describe rates of morbidity and mortality among patients with severe but not critical aortic stenosis in the interval from referral/indication for valvular replacement to intervention. Project Design: The study is a prospective cohort study of patients with severe aortic stenosis referred for aortic valve replacement. All referrals for aortic valve replacement will be allocated to either "transcatheter aortic valve replacement (TAVR)/ surgical aortic valve replacement (SAVR) (standard of care)" or "deferred intervention" based on prespecified criteria. Patients with critical aortic stenosis as defined by an aortic valve area (AVA) <0.6 cm2 or a transvalvular mean gradient of >60 mmHg or a history of cardiac decompensation during the previous 3 months or clinical symptoms on minimal exertion (NYHA III) will be allocated to TAVR or SAVR. All other patients with severe aortic stenosis defined by an AVA <1.0 cm2 will be scheduled for a deferred intervention.

The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.