Trials
Department of Vascular Surgery, West China Hospital, Sichuan University, 37 Guo Xue Alley, Chengdu, 610041, Sichuan Province, China.
Published: May 2022
Background: Covered stent has become one of the mainstream therapies for aortoiliac obstructive disease (AIOD), with a higher patency rate than bare metal stent. Covered balloon-expandable (CBE) stent can be placed more accurately with higher a radial support force, while covered self-expanding (CSE) stent has greater elasticity and higher trackability. However, there is no level I evidence regarding the comparison safety and efficacy between the CSE stent and CBE stent in AIOD to date. Therefore, this study aims to compare the efficacy and safety of CBE stent (BARD®LIFESTREAM™) and CSE stent (GORE® VIABAHN™) in AIOD.
Methods: This trial is a prospective, single-center, parallel, noninferiority, randomized controlled trial. A total of 106 patients will be enrolled and these patients will be randomized to either the CBE stent group or the CSE stent group. The primary end point of the study is the occurrence of target lesion revascularization (TLR) at 12 months after the intervention.
Discussion: To our knowledge, the ballooN sElf cOver steNt AorToiliAc occuLusive (NEONATAL) trial is the first RCT to compare CBE and CSE stent in AIOD patients. The main aim is to compare the TLR of the target lesion between CBE stent and CSE stent at 12 months post-procedure. The results of clinical trials may contribute to establishing a strategic guideline for choosing the optimal type of covered stent in the treatment of AIOD patients.
Trial Registration: Chinese Clinical Trials Registry ChiCTR2100046734. Registered on 27 May 2021.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097112 | PMC |
http://dx.doi.org/10.1186/s13063-022-06332-7 | DOI Listing |
ACS Appl Mater Interfaces
August 2023
The department of Ophthalmology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu 610072, Sichuan, China.
Cureus
December 2022
Vascular Surgery, East Suffolk and North Essex NHS Foundation Trust, Colchester, GBR.
Introduction: Femoropopliteal and femorodistal bypasses are indicated in the management of severe claudication or critical limb ischaemia. The choice of type of anaesthesia between general anaesthesia (GA) and regional anaesthesia (RA; epidural/spinal) has remained controversial. The study aimed to compare the rates of graft failure, perioperative mortality, and other major complications (including graft failure) associated with GA versus RA for lower limb bypass revascularisation in patients presenting with significant peripheral arterial disease.
View Article and Find Full Text PDFTrials
May 2022
Department of Vascular Surgery, West China Hospital, Sichuan University, 37 Guo Xue Alley, Chengdu, 610041, Sichuan Province, China.
Background: Covered stent has become one of the mainstream therapies for aortoiliac obstructive disease (AIOD), with a higher patency rate than bare metal stent. Covered balloon-expandable (CBE) stent can be placed more accurately with higher a radial support force, while covered self-expanding (CSE) stent has greater elasticity and higher trackability. However, there is no level I evidence regarding the comparison safety and efficacy between the CSE stent and CBE stent in AIOD to date.
View Article and Find Full Text PDFAnn Transl Med
July 2021
Stroke Monitoring and Diagnostic Division, AtheroPoint™, Roseville, CA, USA.
Cardiovascular disease (CVD) is one of the leading causes of morbidity and mortality in the United States of America and globally. Carotid arterial plaque, a cause and also a marker of such CVD, can be detected by various non-invasive imaging modalities such as magnetic resonance imaging (MRI), computer tomography (CT), and ultrasound (US). Characterization and classification of carotid plaque-type in these imaging modalities, especially into symptomatic and asymptomatic plaque, helps in the planning of carotid endarterectomy or stenting.
View Article and Find Full Text PDFCirculation
May 2014
From the ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS 1166, Université Paris 6, Paris, France (G.M., J.S., O.B., P.S., S.A.O., M.K., J.-P.C.); Hôpital Louis Pasteur, Le Coudray, France (G.R.); Hôpital de la Timone, Marseille, France (J.-L.B., T.C.); CH de Bastia, Bastia, France (Z.B.); CHU Carémeau, Nîmes, France (G.C.); CH de la Région Annecienne, Annecy, France (L.B.); Hôpital Cardiologique, Lille, France (E.V.B.); CH de Lagny, Marne-la-Vallée, France (S.E.); Clinique Sainte-Clothilde, La Réunion, France (C.P.); Hôpital Lariboisière, Paris, France (P.H.); CHU Clermont-Ferrand, Clermont-Ferrand, France (P.M.); Hôpital de Rangueil, Toulouse, France (D.C.); Unite de Recherche Clinique, Hôpital Lariboisière, ACTION Study Group, Paris, France (H.R., E.V.); Hôpital Bichat, Paris, France (P.A.); HIA du Val-du-Grâce, Paris, France (J.M.); Hôpital Bichat, ACTION Study Group, Paris, France (J.A.); Hôpital Trousseau, Chambray-lès-Tours, ACTION Study Group, Paris, France (C.S.-E.); and CHU Côte de Nacre, Caen, ACTION Study Group, Caen, France (F.B.).
Background: Individualizing antiplatelet therapy after platelet function testing did not improve outcome after coronary stenting in the Assessment by a Double Randomization of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption Versus Continuation One Year After Stenting (ARCTIC) study. Whether results are different during the phase of secondary prevention starting after hospital discharge, when periprocedural events have been excluded, is unknown.
Methods And Results: In ARCTIC, 2440 patients were randomized before coronary stenting to a strategy of platelet function monitoring (VerifyNow P2Y12/aspirin point-of-care assay) with drug adjustment in suboptimal responders to antiplatelet therapy or to a conventional strategy without monitoring and without drug or dose changes.
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