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Constriction, Pathologic clinical trials

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NCT ID: NCT04299906 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

SOLARIS Peripheral PMCF Trial

Start date: May 17, 2021
Phase: N/A
Study type: Interventional

The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to the indications of the IFU.

NCT ID: NCT04232670 Active, not recruiting - Clinical trials for Pancreatic Duct Stone

Pancreatic Endotherapy for Refractory Chronic Pancreatitis

PERCePT
Start date: October 9, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether endoscopic ultrasound (EUS) only versus EUS + endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic endotherapy reduces pain in the treatment of chronic pancreatitis with pancreatic duct obstruction.

NCT ID: NCT04206228 Active, not recruiting - Iron-deficiency Clinical Trials

Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

IIISAS
Start date: January 2, 2020
Phase: Phase 2
Study type: Interventional

Iron deficiency is a prevalent nutritional deficiency and a common cause of anemia. Although iron deficiency is traditionally linked to anemia, iron deficiency is prevalent even in the absence of anaemia and in itself limits function and survival. Iron deficiency is a common feature of various chronic diseases, and up to 50% of patients with heart failure have iron deficiency. Iron deficiency is more prevalent the more advanced the disease is and occurs more frequently in women. Iron deficiency comprises absolute iron deficiency (usually defined as ferritin < 100 ng/ml) as well as functional iron deficiency, in which iron supply is inadequate to meet the demand for the production of red blood cells and other cellular functions despite normal or abundant body iron stores. Iron deficiency is associated with poor exercise capacity, lethargy and reduced quality of life. Results from our studies have shown that iron deficiency is prevalent in patients with aortic stenosis. Some of the symptoms associated with aortic stenosis, such as fatigue, reduced exercise capacity, dyspnoea and cognitive dysfunction, have traditionally been thought to be caused by the haemodynamic derangements precipitated by the valvular stenosis. However, similar symptoms can be brought about by iron deficiency, and the investigators hypothesize that intravenous iron supplement will improve exercise capacity, muscle strength, cognition, health-related quality of life and myocardial function in patients with severe aortic stenosis and iron deficiency. This is a phase 2, double blind, randomised, placebo-controlled trial. Participants will be randomised in a 1:1 fashion to receive a single intravenous dose of iron isomaltoside (50 patients) or matching placebo (50 patients). The study is designed to show superiority with regard to the primary endpoint in patients assigned to active treatment versus patients allocated to the placebo arm. The main goal is to evaluate the effect of a single dose of intravenous iron isomaltoside on exercise capacity after transcatheter aortic valve implantation in patients with severe aortic stenosis and iron deficiency. For this study, the investigators have defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %.

NCT ID: NCT04201132 Active, not recruiting - Carotid Stenosis Clinical Trials

Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System

PERFORMANCE II
Start date: June 12, 2020
Phase: N/A
Study type: Interventional

A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA).

NCT ID: NCT04192747 Active, not recruiting - Clinical trials for Coronary Artery Disease

The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries

BIOADAPTOR RCT
Start date: December 16, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions

NCT ID: NCT04160130 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)

RHEIA
Start date: November 29, 2019
Phase: N/A
Study type: Interventional

Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female patients with severe symptomatic aortic stenosis. Patients will be randomized 1:1 to receive either TAVI or SAVR aortic valve replacement. For TAVI procedure, Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3 Ultra THV system Model 9750 TFX (20, 23, 26) with the associated transfemoral delivery systems will be sued, for SAVR any commercially available surgical bioprosthetic valve. Patients will undergo the following visits: Screening, Procedure, Post Procedure, Discharge, 30 day, 6 months (telephone contact) and 1 year.

NCT ID: NCT04067089 Active, not recruiting - Aortic Stenosis Clinical Trials

Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR

TEAm-BR
Start date: December 10, 2018
Phase: N/A
Study type: Interventional

TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil. The study is sponsored by the national Minister of Health, through PROADI-SUS (Programa de Apoio ao Desenvolvimento Institucional do SUS).

NCT ID: NCT04061213 Active, not recruiting - Amyloidosis Cardiac Clinical Trials

ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

Start date: August 26, 2019
Phase:
Study type: Observational [Patient Registry]

Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) > 40mmHg and a calculated aortic valve area of < 1cm2. However, a considerable proportion of patients do have a MTPG < 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface area ≤ 35ml/m2) despite a normal left ventricular ejection fraction (LVEF > 50%). This entity is termed paradoxical low flow low gradient aortic stenosis (PLFLG AS) and is associated with a worse prognosis. ATTR amyloidosis is a disease of the elderly and might coexist in patients with severe aortic stenosis. Case reports and small observational studies suggest that senile ATTR amyloidosis could be frequent but underdiagnosed in patients with aortic stenosis. There is significant overlap between PLFLG AS and cardiac amyloidosis with regard to symptoms, increasing prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle (LV), as well as longitudinal LV dysfunction despite preserved ejection fraction - all features, which lead to a reduction in stroke volume, the underlying mechanism of the low flow condition as observed in PLFLG AS patients.

NCT ID: NCT04023370 Active, not recruiting - Clinical trials for Iliac Artery Stenosis

Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System

Start date: September 19, 2019
Phase: N/A
Study type: Interventional

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

NCT ID: NCT04011722 Active, not recruiting - Clinical trials for Symptomatic Severe Aortic Stenosis

Portico NG Approval Study

Start date: September 17, 2019
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.