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Constriction, Pathologic clinical trials

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NCT ID: NCT04666584 Active, not recruiting - Clinical trials for Coronary Artery Disease

Optimal Predilatation Treatment Before Implantation of a Magmaris Bioresorbable Scaffold in Coronary Artery Stenosis

OPTIMIS
Start date: December 14, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to investigate if lesion preparation with a ScoreFlex balloon compared to a standard non-compliant balloon improve vascular healing and minimize lumen reduction after implantation of a Magmaris bioresorbable scaffold.

NCT ID: NCT04665596 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis

Start date: December 23, 2019
Phase: N/A
Study type: Interventional

This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human

NCT ID: NCT04655742 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial

Start date: June 27, 2014
Phase: N/A
Study type: Interventional

This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

NCT ID: NCT04594980 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Minimally Invasive Decompression and Fusion Versus Open for Degenerative Lumbar Stenosis

Start date: January 20, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effectiveness of minimally invasive decompression and fusion over the traditional open decompression and fusion in patients with single-level lumbar stenosis caused by degenerative spondylolisthesis. Postoperative follow-up will continue for 12 months. Сlinical, safety, radiological and cost-effectiveness endpoints will be evaluated.

NCT ID: NCT04540302 Active, not recruiting - Venous Occlusion Clinical Trials

The Merit WRAPSODY AV Access Efficacy Study (WAVE)

WAVE
Start date: March 9, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit

NCT ID: NCT04514250 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients

SAVI-AoS
Start date: April 14, 2021
Phase:
Study type: Observational [Patient Registry]

Discrepancies exist among aortic stenosis severity classification, patient symptom burden, and - in some cases - even survival. The new Stress Aortic Valve Index (SAVI) metric correlates better with transvalvular flow and might be a better predictor of symptoms and prognosis. The current study will demonstrate the value of SAVI (both non-invasive and invasive) in patients with moderate aortic stenosis. The population will consist of subjects at least 50 years old with moderate aortic stenosis (defined as aortic valve area >1.0 cm2 plus either maximal velocity 2.5-3.9 m/s or mean gradient 15-39 mmHg). Subjects with severe concomitant valve disease or severe unrevascularized coronary artery disease will be excluded, so that the isolated prognosis of aortic stenosis can be investigated. All subjects will undergo invasive SAVI measurements during catheterization. Furthermore patients will receive non-invasive testing with an exercise echocardiogram and computed tomography (CT) scan for non-invasive SAVI measurements. The short-term objective will compare SAVI with standard resting indexes for symptom burden, functional capacity, and biomarkers. The long-term objective will associate SAVI and standard resting indexes with clinical outcomes related to valvular disease. The investigators hypothesize that low SAVI (more marked AS during stress) will track with more symptoms and a worse prognosis. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients will have several study visits. The index visit will be planned to obtain informed consent and baseline parameters. The measurement visit(s) will consist of the invasive SAVI measurement, echocardiogram, stress echo imaging, 6-minute walk test, quality of life questionnaire, and the cardiac CT. During the final visit after 12 months, subjects will undergo a CT valvular calcium scan, quality of life questionnaire, and 6-minute walk test. Every subject will have an echocardiogram yearly as suggested by guideline criteria and could possibly be contacted until five years after enrollment. Blood samples will be drawn at baseline and the 1-year follow-up. Potentially the new SAVI metric could identify patients at higher risk among those with moderate gradient AS. However, since no outcome data currently exists regarding SAVI and prognosis, no conclusions could be derived from these measurements until study completion.

NCT ID: NCT04492774 Active, not recruiting - Clinical trials for Spinal Stenosis Lumbar

Degenerative Lumbar Stenosis Conservative Treatment

GOLDSTEN
Start date: July 1, 2020
Phase: Phase 4
Study type: Interventional

The trial aims to compare the effectiveness of three methods of conservative treatment of degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections, steroid epidural injections and manual therapy.

NCT ID: NCT04420325 Active, not recruiting - Clinical trials for Coronary Artery Disease

COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.

COMIC-AS
Start date: June 1, 2020
Phase:
Study type: Observational

Although concomitant coronary artery disease (CAD) is frequent in patients with severe aortic stenosis (AS), hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe AS is challenging. Myocardial hypertrophic remodeling interferes with coronary blood flow and may influence the values of fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs). The aim of the current study is to investigate the effect of the AS and its treatment on current indices used for evaluation of CAD. The investigators will compare intracoronary hemodynamics before, immediately after, and 6 mo after aortic valve replacement (AVR) when it is expected that microvascular function has improved. Furthermore, the investigators will compare FFR and resting full-cycle ratio (RFR) with myocardial perfusion single-photon emission-computed tomography (SPECT) as indicators of myocardial ischemia in patients with AS and CAD. One-hundred consecutive patients with AS and intermediate CAD will be prospectively included. Patients will undergo pre-AVR SPECT and intracoronary hemodynamic assessment at baseline, immediately after valve replacement [if transcatheter AVR (TAVR) is chosen], and 6 mo after AVR. The primary end point is the change in FFR 6 mo after AVR. Secondary end points include the acute change of FFR after TAVR, the diagnostic accuracy of FFR versus RFR compared with SPECT for the assessment of ischemia, changes in microvascular function as assessed by the index of microcirculatory resistance (IMR), and the effect of these changes on FFR. The present study will evaluate intracoronary hemodynamic parameters before, immediately after, and 6 mo after AVR in patients with AS and intermediate coronary stenosis. The understanding of the impact of AVR on the assessment of FFR, NHPR, and microvascular function may help guide the need for revascularization in patients with AS and CAD planned for AVR.

NCT ID: NCT04391790 Active, not recruiting - Bladder Cancer Clinical Trials

MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy

MOSAIC
Start date: May 27, 2020
Phase: N/A
Study type: Interventional

Cystectomy is the chosen treatment of bladder cancer in 400 cases every year in DK. In replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (Ad Modum Bricker). Ureteral strictures are diagnosed in 15% of the cystectomized patients, and these patients are at increased risk of infections, loss of renal function and repeated interventions. The left ureter is diagnosed with 70% of all strictures, presumably due to the construction of the urinary diversion. A modified urinary diversion have been tested in two small studies. The modified diversion is prolonged with 5cm compared to the conventional urinary diversion. The prolongation permits the urinary diversion to reach both the left and the right side of the abdomen, resulting in greater resection of non-viably distal ureter and less mobilization of the left ureter, lowering the rates of strictures.

NCT ID: NCT04374669 Active, not recruiting - Sarcopenia Clinical Trials

Sarcopenia and Outcomes of Neuroplasty in Lumbar Spinal Stenosis

Start date: May 20, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of the present study is to find out the influence of sarcopenia on outcomes of neuroplasty in patients with lumbar spinal stenosis.