Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR
Aortic StenosisTEAM-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).
PrizValve® Transcatheter Aortic Valve Replacement Study
Aortic Valve StenosisThe purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific...
Aortic StenosisTo observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance criteria.
Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
Aortic Valve StenosisThis 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-man
Effect of Evolocumab on Carotid Plaque Composition in Asymptomatic Carotid Artery Stenosis (EVOCAR-1)...
Carotid Artery StenosisThis is a phase IV, randomised, placebo-controlled, double-blind, parallel group study to determine the effect of Evolocumab treatment on carotid plaque morphology and composition in asymptomatic patients with >50% carotid artery stenosis.
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic...
Severe Aortic StenosisThe purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.
LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis...
Degenerative SpondylolisthesisLumbar Spinal StenosisThe LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.
EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic...
Heart DiseasesAortic Stenosis1 moreThis study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture...
Urethral StrictureROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).
DIGEST I Drug Coated Balloon for Biliary Stricture
Biliary StrictureBiliary Anastomotic Stenosis2 moreDIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.