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Constriction, Pathologic clinical trials

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NCT ID: NCT05010980 Recruiting - Clinical trials for Aortic Valve Stenosis

Early Detection of Cardiac Amyloidosis

Start date: August 1, 2021
Phase:
Study type: Observational

Due to a lack of therapeutic options, the diagnosis of cardiac (wt)-ATTR amyloidosis was for a long time overshadowed by other diseases and therefore was or still is often diagnosed with considerable delay. The aim of the study is to estimate the prevalence of cardiac amyloidosis among patients with mild-to-moderate aortic valve stenosis (AS). Besides that a screening algorithm based on echocardiographic parameters will be developed, to facilitate the early detection of cardiac amyloidosis.

NCT ID: NCT05009212 Recruiting - Crohn Disease Clinical Trials

Endoscopic Stricturotomy Versus Endoscopic Balloon Dilatation in Patients With Crohn's Disease and Symptomatic Small Bowel Stricture

DESTRESS
Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection. Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The European Crohn's and Colitis Organisation (ECCO) guideline recommended that endoscopic balloon dilatation is suitable to treat short [<5 cm] strictures of the terminal ileum in CD. Recently, Lan et al. reported that endoscopic stricturotomy appeared to be more effective in treating CD patients with anastomotic stricture than endoscopic balloon dilatation. However, there is no prospective clinical studies evaluating the efficacy and safety of endoscopic stricturotomy in the treatment of fibrostenotic Crohn's disease. The trial aims to compare the efficacy and safety of endoscopic stricturotomy with endoscopic balloon dilation in the treatment of small bowel stricture in patients with Crohn's Disease.

NCT ID: NCT05002751 Recruiting - Vaginal Stricture Clinical Trials

Quantifying Radiation Induced Vaginal Stenosis

QRIVS
Start date: October 6, 2022
Phase:
Study type: Observational

Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements. In addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.

NCT ID: NCT04996173 Recruiting - Pulmonary Disease Clinical Trials

Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

Benign central airway stenosis (BCAS) is an important cause of both pulmonary morbidity and mortality. Notable causes include post-intubation stenosis, collagen vascular diseases, airway trauma, infectious and idiopathic subglottic stenosis (iSGS). Surgery is the preferred definite option; however, the first therapeutic attempt is usually endoscopic to temporarily restore airway patency and symptomatic improvement. Several endoscopic modalities exist for treatment. Most commonly, thermal or laser therapy to make radial incisions into the stenotic lesion, followed by balloon dilation to increase the area of patency. Clinicians may also inject steroids or antineoplastic agents such as mitomycin C. All of these methods have benefits and associated risks. Symptomatic stenosis frequently reoccurs with these methods. For example, the investigators have been doing 3-4 ballon dilations procedures a week at our institution. Spray cryotherapy (SCT) is a novel FDA-cleared technique that allows for liquid nitrogen to be delivered through the working channel of a bronchoscope. Few retrospective studies exist without more robust clinical trial data to reduce the risk of bias and support its widespread use. The investigators postulate that SCT and standard of care techniques will improve airway patency volume at six months than the standard of care techniques alone. Some of the proposed advantages include improved wound healing which may translate to less scar tissue and thus improvements in airway patency for a longer duration of time.

NCT ID: NCT04973540 Recruiting - Clinical trials for Pulmonary Artery Stenosis

A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis

IRIS
Start date: July 13, 2021
Phase: N/A
Study type: Interventional

This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.

NCT ID: NCT04968509 Recruiting - Aortic Stenosis Clinical Trials

Effect of PCSK9 Inhibitors on Calcific Aortic Valve Stenosis

Start date: March 22, 2024
Phase: Phase 3
Study type: Interventional

Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease. In fact, aortic valve replacement remains the only treatment option. CAS has been shown to be associated with Lp(a), LDL-C and PCSK9. Several observational studies indicated that the use of statins to decrease LDL-C levels was associated with the reduced incidence of CAS, but no randomized controlled trials (RCTs) showd that statins had any benefit on the progression of CAS. This may be related to the limited reduction of LDL-C by statin therapy. The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have emerged as a new lipid-lowering drug. On the basis of statin therapy, PCSK9 inhibitors can further reduce LDL-C and Lp(a) levels by 50% to 60% and 20% to 30%, respectively. Some studies reported that elevated plasma PCSK9 levels were related to CAS and PCSK9 R46L loss-of-function mutation was associated with lower rates of CAS, and importantly, some observational studies found that PCSK9 inhibitors could reduce the incidence of CAS. Our trial aims to investigate the effect of PCSK9 inhibitors on preventing or delaying the progression of CAS. A total of 160 patients with mild or moderate CAS or asymptomatic severe AS will be randomly assigned to receive either statins or PCSK9 inhibitors+statins. All patients will be followed for at least 2 years at 3, 6,9,12,15,18,21,24 months after randomization. Quality of life (EQ-5D-3L including the EUROQOL visual analogue scale) questionnaires were gathered during each visit. Echocardiography and computer tomography were performed and blood samples were withdrawn at baseline, at 2 years visit, and before withdrawal from the study. The primary endpoint is the average annual change in peak aortic jet velocity on echocardiography. The secondary endpoints include average annual change in aortic valve area on echocardiography, average annual change in aortic valve calcification score on cardiac non-contrast computer tomography, heart valve surgery, change in quality-of-life scores, and average annual change in aortic and coronary artery calcification. Safety endpoints include all-cause death and cardiovascular events. The results of this trial will provide a new idea for the treatment of patients with CAS.

NCT ID: NCT04947046 Recruiting - Stroke Clinical Trials

Carotid Stenosis Management During COVID-19 Era - Pilot Study

CASCOM-Pilot
Start date: March 11, 2020
Phase:
Study type: Observational

Carotid endarterectomy (CEA) and carotid stenting (CAS) are often performed for subgroups of patients for whom procedural benefit has not been established in randomised trials and despite evidence of serious procedural risk. In some places, the COVID-19 pandemic has made it difficult or impossible to perform CEA and CAS in time. This study aims to measure the rate of ipsilateral stroke and other complications in individuals with symptomatic carotid stenosis, whom for any reason are managed using current best medical intervention alone. The investigators expect at least 50% lowering of the ipsilateral stroke rate compared to that seen with medical intervention alone in past randomised trials.

NCT ID: NCT04929821 Recruiting - Biliary Obstruction Clinical Trials

UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures

Start date: October 16, 2017
Phase: N/A
Study type: Interventional

STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY OBJECTIVES Clinical /Technical /Procedural success, Quality of Life improvement, biodegradation rate

NCT ID: NCT04914481 Recruiting - Clinical trials for Low-Flow, Low-Gradient Aortic Stenosis

Anatomic Stenosis Severity as a Prognostic Marker in Patients With Low-Flow Low-Gradient Aortic Stenosis Undergoing TAVI

ATLAS TAVI
Start date: April 1, 2021
Phase:
Study type: Observational

The ATLAS TAVI Registry is a retrospective, investigator-initiated, multicenter registry including patients, who underwent Transcatheter Aortic Valve Implantation (TAVI) for classical or paradoxical low-flow, low-gradient aortic stenosis (LFLG AS) with available non-contrast MSCT data on aortic valve calcification (AVC). The main objective of this study is the assessment of outcome after TAVI according to AVC density severity in patients with LFLG AS.

NCT ID: NCT04913870 Recruiting - Aortic Stenosis Clinical Trials

Angiotensin Receptor Blockers in Aortic Stenosis

ARBAS
Start date: February 1, 2020
Phase: Phase 4
Study type: Interventional

This study is intended to investigate the effect of angiotensin receptor blockers (ARBs) on mild-to-moderate aortic stenosis.