UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the...
Biliary ObstructionBile Duct Stricture1 moreSTUDY 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
Clinical Trial in China for Aortic Valve Stenosis
Diseases of Aortic ValveAortic Stenosis DiseaseThe 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 disease who are at high or prohibitive surgical risk.
Paclitaxel Drug-eluting Balloon Catheters in the Treatment of Symptomatic Intracranial Atherosclerotic...
StrokeIntracranial Atherosclerotic StenosisThis study is aiming to evaluate the safety and efficacy of SeQuent® Please CIS in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis and restenosis after interventional therapy.
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis...
Spinal Lumbar StenosisClaudication1 moreThe aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis
Carotid Artery StentingCarotid Endarterectomy2 moreThis is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population.
Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients With Lumbar...
Spinal StenosisThe aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC. The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes will be walking capacity measured with the Self-Paced Walking Test and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.
Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis(Timing Trial)
Carotid Artery DiseasesCarotid Artery Stenosis2 moreEvaluate the safety and efficacy of the Timing Carotid Stent for the treatment of carotid artery stenosis in patients.
Radial Versus Femoral Access For Carotid Artery Stenting
Ischemic StrokeCarotid Stenosis2 moreBackground: For moderate to severe carotid artery atherosclerotic stenosis, in the past decades, carotid artery stenting (CAS) has been an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. The transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for CAS. The radial artery is an ideal puncture site for cerebrovascular intervention. Studies have shown that nerve intervention through radial artery approach can complete most cerebrovascular intervention procedures, including cerebral angiography, carotid artery stent implantation, vertebral artery stent implantation, intracranial artery stent implantation, mechanical thrombectomy, aspiration, intra-arterial thrombolysis and so on. However, the current studies are based on single center small sample studies, and there has been still a lack of large sample randomized controlled experiments to verify the safety and effectiveness of CAS in transradial artery (TRA) . Objective: To evaluate the efficacy and safety of CAS via TRA in patients with carotid artery stenosis through a multicenter, prospective and randomized study. Study design: This study is a randomized, open label, multicenter, parallel controlled trial. A non-inferiority test is performed to compare the primary end point between the experimental group and the control group. The experimental group will undergo carotid stent implantation via radial artery approach, while the control group will use femoral artery approach. Study population: Adult patients with symptomatic carotid-artery stenosis ≥50% or asymptomatic stenosis ≥70%. Study outcomes: Primary end points: The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure Secondary end points:1. The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure. 2. The incidence of death within 48 hours / 30 days post-procedure. 3. The incidence of new-onset stroke within 48 hours / 30 days post-procedure. 4. The incidence of myocardial infarction within 48 hours / 30 days post-procedure. 5. The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure. Other end points: 1. Successful rate of DSA. 2. Successful rate of endovascular treatment. 3. Degree of patient-reported comfort. 4. Operation time 5. NIHSS score changes post-operation.6. mRS score score changes post-operation. 7. X-ray exposure. Safety outcomes: 1.Occurrence of all adverse events. 2. AEs related to operation and device. 3. Incidence of adverse event of special interest.
Portico and Navitor India Clinical Trial
Aortic Valve StenosisAortic Valve Failure2 moreThe objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian population.
DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis
Femoral Artery StenosisPopliteal Artery StenosisA Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis