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Stent Stenosis clinical trials

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NCT ID: NCT05947994 Recruiting - Ischemic Stroke Clinical Trials

Credo Stent in the Symptomatic Intracranial Stenosis

CRESIS
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

In the symptomatic ischemic stroke, the decision-making of medical treatment plus intracranial stenting (IS) has been more and more popular, especially in patients with intracranial large severe stenosis or occlusive artery. Nonetheless, there were few evidences evaluating the comprehensive information of the other self-expanding stent relating IS procedure after positive results of the Wingspan Stent System Post Market Surveillance (WEAVE) trial and Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) study about Wingspan stent. The aim of our study was to investigate whether IS with Credo stent would improve the adverse events during 1-year follow-up.

NCT ID: NCT05809310 Recruiting - Clinical trials for Congenital Heart Disease

Effects Branch PA Stenting d-TGA, ToF and TA

Start date: April 18, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The main question[s] it aims to answer are: The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions. Participants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions. Researchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)

NCT ID: NCT05761496 Recruiting - Biliary Stricture Clinical Trials

Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures.

PROTESIED
Start date: January 7, 2020
Phase:
Study type: Observational [Patient Registry]

Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures

NCT ID: NCT05666388 Completed - Thrombosis Clinical Trials

Rescue Stenting in the Severe Atherosclerotic Stenosis After the Failure of Intravenous Thrombolysis

RESFIT
Start date: May 1, 2020
Phase: N/A
Study type: Interventional

Intravenous (IV) recombinant tissue plasminogen activator is the standard of care for patients with acute ischemic stroke (AIS) who present to the hospital within 4.5 hours of symptom onset. However, IV thrombolysis, even bridging thrombolysis (combining intravenous thrombolysis and mechanical thrombectomy) has limited efficacy among patients who had occlusive lesions associated with highgrade arterial stenosis requiring revascularization to improve neurological deficits. The investigators evaluated whether rescue stenting results in good outcomes among patients after the failure of intravenous thrombolysis and bridging thrombolysis.

NCT ID: NCT04986774 Completed - Ischemic Stroke Clinical Trials

Rescue Intracranial Stenting in Acute Ischemic Stroke

RISIS
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

In acute ischemic stroke caused by intracranial large vessel occlusion, rescue intracranial stenting has been recently a treatment option to achieve recanalization in patients with the failure of mechanical thrombectomy. Nevertheless, there are few studies supporting this beneficial treatment in two cerebral circulations. We aimed to analyse whether the use of rescue intracranial stenting would improve prognosis of patients at 3 months.

NCT ID: NCT04715594 Active, not recruiting - Clinical trials for Coronary Artery Disease

CONNECT DES Registrty

Start date: August 11, 2019
Phase:
Study type: Observational

To date, drug-eluting stents (DES) have become the standard of care in daily practice for the treatment of ischemic heart disease, by overcoming the risk of in-stent restenosis, a major issue raised in the bare-mare stents era. The application of potent anti-proliferative drugs and polymer structures that ensures sustained released of the drugs markedly reduced the neointimal hyperplasia, leading to much improved clinical outcomes compared with bare-metal stents. However, although first-generation sirolimus-eluting stents and paclitaxel-eluting stents significantly reduced the risk of in-stent restenosis and target-vessel revascularization, an augmented risk for very late stent thrombosis and fatal clinical events emerged as a new issue to be solved. Second- and newer- generation DESs adopted innovative stent platforms, novel stent materials, anti-proliferative drugs, and biocompatible polymers (including both durable and bioresorbable). Nowadays, numerous types of DESs (over 20 types) are available in clinical practice as well as bare-metal stents. However, little is known about the clinical outcome according to type of DESs in real-word practice. Given that many of recent randomized clinical trials (RCTs) demonstrate the 'non-inferiority' of brand-new DESs over older DESs in limited period time (usually for 1-year) in a selected patients eligible for RCTs, the real-world clinical outcomes according to type of DES implanted are still unveiled. Although, the question about the differential impact of generation of DES, type of biocompatible polymers (bioresorbable versus durable), thickness of stent struts and type of eluted anti-proliferative drugs are very important in clinical aspect of view, but there is little study conducted on all patients who are actually confronted in daily clinical practice. Korea operates national insurance system that covers most of the Koreans (97.1%) that are strictly monitored by National Health Insurance Service (NHIS). Of note, the claims database of NHIS of Korea contains all information including the demographic characters of patietns, diagnosis codes (ICD-9 and ICD-10), type of procedures or surgeries and the medical devices utilized, death certificates that contains type of death, and the drugs prescribe in outpatient clinic and hospitals in a individual pill level, that enables monitoring for the drug compliance. This unique feature of NHIS database allows the investigators to gain access to the dose and duration of cardio-protective medications including anti-platelet agents, lipid-lowering agents, anti-hypertensive agents, glucose-lowering agents, nitrate donors, vasodilators, and others. Given the benefits of NHIS database of Korea, we would like to establish a whole-population registry, named as COreaN NationwidE Claims daTa on Drug-Eluting Stent Registry (CONNECT DES Registry). A comprehensive analysis of this data is expected to shed new light on the impact of type of DESs and drug use in real-world practice that could be fully revealed through RCTs.

NCT ID: NCT04192760 Recruiting - Coronary Stenosis Clinical Trials

Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions

BBK-3
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Randomised comparison of Culotte technique versus "Double Kissing" - Crush technique (DK-Crush) for the percutaneous treatment of de novo non-left main coronary bifurcation lesions with modern everolimus-eluting stents (DES) - German multicenter study

NCT ID: NCT04128956 Terminated - Venous Thromboses Clinical Trials

Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS

ARIVA
Start date: March 11, 2020
Phase: Phase 2
Study type: Interventional

To show if a combination therapy of rivaroxaban plus Aspirin® is more efficient (superiority testing) as rivaroxaban alone in the prevention of early venous stent thrombosis in patients suffering from post-thrombotic syndrome in the first 6 months following endovascular therapy To demonstrate tolerability of combination therapy of Aspirin® plus rivaroxaban in long-term treatment.

NCT ID: NCT03586739 Recruiting - Stent Stenosis Clinical Trials

Evaluation of Covered Stents Versus Bare Metal Stents for Endovascular Treatment of Chronic Ischemia Mesenteric Disease.

ESTIMEC
Start date: December 12, 2018
Phase: N/A
Study type: Interventional

Chronic Mesenteric Ischemia (CMI) is defined by one or more arterial digestive lesions, responsible for severe mesenteric symptoms. The clinical presentation of CMI is characterized by postprandial abdominal pain and weight loss, leading to severe malnutrition. It is a frequent pathology which affects preferentially the elderly patients of female sex (70%) with cardio-vascular comorbidities. Risk factors include smoking, hypertension, and dyslipidemia. Despite medical and diagnostic advances, the morbidity and mortality of CMI remain very high (>70%). Optimal management of CMI is based on early diagnosis. Symptomatic patients with CMI should be treated without much delay to relief symptoms (present in 43% patients) and prevent acute mesenteric ischemia. The three visceral arteries affected by atherosclerotic disease are coeliac trunc, inferior mesenteric artery and Superior Mesenteric Artery (SMA). The SMA is treated the most frequently, because it is the main relevant artery associated with CMI. Endovascular treatment (angioplasty and stenting) is considered as the first-line treatment for CMI when feasible. It is indicated especially in the case of high grade stenosis or occlusion of the Superior Mesenteric Artery. Two types of stents can be used for this procedure: bare metal stents (BMS) or covered stents (CS). Even if BMS are standard care there is no consensus on the type of stent to use. There are very few reported series with large numbers of patients comparing BMS and CS in this indication. However, to our knowledge, no results from a randomized study addressing this issue have ever been published. These are only retrospective with a low level of evidence (IIb). The largest series compared 147 patients with primary intervention for CMI treatment using BMS versus 42 using CS. Treatment with CS showed better results in terms of symptom recurrence (10% vs 32%, p <0.002), restenosis (12% vs 42%, p <0.0002) and re-interventions (10% vs 42%), after at least 1 year of follow-up. Indeed, endovascular treatment using BMS was associated with high incidence of symptoms recurrence despite the satisfying patency rates in both occluded and stenotic vessels. There are no international guidelines to recommend the use of one or another sort of stent. The necessity of a randomised study addressing the issue of bare metal versus covered stents deployment seems to be important. The investigators propose to demonstrate that covered stents presents a better efficacy than bare metal stents, with a multicenter randomized study involving 24 vascular surgical departments of French University Hospitals.

NCT ID: NCT03373292 Not yet recruiting - Headache Clinical Trials

Endovascular Stenting Treatment for Patients With Internal Jugular Vein Stenosis

Start date: January 2018
Phase: Phase 1
Study type: Interventional

This is a prospective, randomized, single-center clinical study aiming to explore the safety and efficacy of venous stenting for patients with internal jugular vein stenosis (IJVS).