Bartlesville

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating the effect of dalcetrapib on cardiovascular risk in people recently hospitalized for acute coronary syndrome ACS who have a specific genetic profile AA genotype. This phase 3, randomized, double-blind, placebo-controlled study focuses on adults aged 45 years and older, aiming to assess the time to first occurrence of fatal or non-fatal myocardial infarction over an average of 30 months from randomization. The study will continue until around 200 participants experience a primary event, or until stopped at an interim analysis. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily, two 300 mg tablets or matching placebo tablets once daily. Screening includes genetic testing for the AA genotype using a specialized Genotype Assay Test. Enrollment can begin during hospitalization or after discharge, but randomization must occur within 12 weeks of the ACS event. After randomization, follow-up visits will be virtual when possible or in clinic every three months until the study ends. Assessments will continue every three months for participants who stop the study medication early. Participants will undergo medical history review and genetic testing before enrollment. During the study, researchers will monitor cardiovascular events such as heart attacks and strokes through regular assessments every three months. Safety evaluations and collection of study endpoints will continue for the duration of participation, which may last approximately 30 months or until the study stops. This includes ongoing monitoring for adverse effects and overall health status.

Researchers are evaluating a medical procedure that uses a commercially available catheter called the Bullfrog Micro-Infusion Device to deliver an anti-inflammatory drug, dexamethasone sodium phosphate injection, locally around deep veins after removing blood clots DVT recanalization. This study focuses on patients who had deep vein thrombosis symptoms for up to 14 days before the initial clot removal. The goal is to determine if reducing local inflammation can help prevent new clots from forming and improve symptoms for up to 24 months after treatment. Participants receive either the anti-inflammatory drug dexamethasone delivered around the target vein segment or a saline solution as a comparison, both using the same device. This is a randomized, quadruple-masked trial where neither the participants, care providers, investigators, nor outcomes assessors know which treatment is given. The study includes treatment of acute femoropopliteal DVT located in major veins of the leg, with successful clot removal prior to treatment. The study treatment is combined with prescribed anticoagulant and antiplatelet medications for up to 12 months post-procedure. During the study, participants will complete questionnaires and attend follow-up visits to monitor their condition and treatment effects. Researchers will assess outcomes including the rate of keeping the vein open primary patency at 6 months, prevention of post-thrombotic syndrome progression at 6 months, and freedom from major adverse events at 30 days. Participants will be followed for up to 24 months to evaluate long-term benefits and safety of the treatment.

Researchers are evaluating the safety and effectiveness of the Artix Thrombectomy System in patients who have acute blockages in the arteries of the lower limbs. This post-market, prospective, multicenter, single-arm study focuses on treating acute lower limb arterial occlusion in adults aged 18 years and older. The study aims to better understand the outcomes of using this device to remove arterial clots. Participants will receive treatment using the Artix Thrombectomy System, a device designed to remove emboli and thrombi from the lower extremity arteries without surgery. The treatment targets native vessels with occlusions below the inguinal ligament and vessel sizes between 3 mm and 8 mm. The study observes patients immediately after the procedure and follows them for up to one month to assess safety and effectiveness outcomes. During the study, participants will be monitored for immediate procedure success and safety within 48 hours. Follow-up assessments at one month will include evaluations of mortality, limb salvage, and amputation-free survival. Researchers will collect data on adverse events like distal embolization and overall survival. Throughout the study, patients will undergo clinical assessments and safety monitoring to track their progress and responses to the treatment.

Researchers are evaluating the Thor system in adults aged 18 years and older who have new, untreated calcified blockages in leg arteries caused by peripheral artery disease PAD. The study aims to determine whether the Thor system is safe and effective for treating these lesions. Patients experience leg pain due to poor blood flow, and the study will observe how the Thor system works in this setting. All participants will receive treatment using the Thor laser atherectomy system, which targets calcified lesions to improve blood flow. During the procedure, doctors may also use additional devices such as angioplasty balloons, drug-coated balloons, stents, and clot-collecting filters if needed. The procedure includes x-ray imaging, and patients will be monitored closely until discharge or for up to 24 hours after treatment. Participants will have follow-up visits at discharge, 30 days, 6 months, and 12 months after the procedure. These visits include medical history reviews, physical exams of the legs, blood flow tests using arm and leg blood pressure comparisons, ultrasound imaging, and questionnaires about walking ability and quality of life. The study will measure outcomes such as freedom from major adverse events, procedural success, lesion openness, and improvements in walking and health surveys over one year.

The trial investigates the adjunctive effectiveness and safety of the TIVUS Renal Denervation System in adults with hypertension. It focuses on subjects with uncontrolled hypertension taking up to two different anti-hypertensive drugs who will stop these medications during the study, as well as subjects with controlled hypertension taking one to two anti-hypertensive drugs who also agree to a medication wash-out period. This international, multicenter, randomized, double-blind, sham-controlled study aims to evaluate blood pressure reduction and safety outcomes in these groups. Participants will undergo a 4-week medication wash-out period before receiving either the TIVUS Renal Denervation procedure or a sham angiogram procedure. After the procedure, subjects remain off anti-hypertensive medications for two months. Subjects with uncontrolled hypertension restart medications following a specific escalation protocol two months after the procedure. The sham procedure is minimally invasive, and unblinding occurs six months post-procedure, with crossover to the TIVUS treatment allowed for uncontrolled sham subjects. Those treated with TIVUS will be followed up to 36 months. Throughout the study, participants will have their blood pressure monitored using daytime ambulatory systolic blood pressure measurements and other blood pressure assessments. Researchers will also track major adverse events within 30 days and six months after the procedure. Participants will undergo renal imaging to confirm eligibility and will have follow-up visits for up to three years. The study carefully monitors safety, medication adherence, and blood pressure changes to evaluate the TIVUS systems performance.