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Endovascular Biopsy and Endothelial Cell Gene Analysis in Endovascular Procedures
Rochester, Minn.
The purpose of this study is to determine endothelial gene expression from guidewire biopsy during clinically indicated endovascular procedures. The genetic analysis will be measured against clinical outcomes and treatment response (response to non-coated and drug-coated technologies and different embolic agents depending on the procedure).
Closed for Enrollment
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A Phase 0 Study to Evaluate the Pharmacokinetics of Low-Dose Avastin and its Efficacy on Reducing Free Plasma VEGF-A in Hemodialysis Patients
Rochester, Minn.
The purpose of this study is to see how hemodialysis patients respond to a very low dose of Avastin (bevacizumab) by measuring the concentration of the medication in the blood and determine how it affects a certain protein that we believe is partially responsible in the vascular narrowing process.
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A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b When Added to Standard of Care Anticoagulation Therapy in Subjects With Acute Submassive Pulmonary Embolism
Rochester, Minn.
This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic Research Organization ARO and Clinical Research Organization CRO blinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in subjects with acute submassive pulmonary embolism.
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A Phase 2B Randomized Double Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection as Adjunct to Revascularization of Infrapopliteal Lesions in Subjects with Advanced Peripheral Artery Disease and Tissue Loss (STOP-PAD)
Rochester, Minn.
To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 2 days and 3 months following the procedure.
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A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
Rochester, Minn.
The purpose of this study is to determine the success of mesenchymal stem cells, developed from the patient's own fat tissue, for reducing hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.
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Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial (ATTRACT)
Rochester, Minn.
The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.
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Aortic, Peripheral & Venous (APV) Product Surveillance Registry Platform Base Clinical Investigation
Rochester, Minn.
The purpose of this study is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use, to obtain real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used to support post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/ or regulatory authority requests, to obtain clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions and to provide clinical data to support health economics and clinical outcomes research.
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ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial (ENDOMAX)
Rochester, Minn.
The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in subjects undergoing peripheral endovascular interventions (PEI). The secondary objective is to identify potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.
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