Bartlesville

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are studying a medical procedure that uses the Bullfrog® Micro-Infusion Device to deliver the anti-inflammatory drug dexamethasone sodium phosphate injection around deep veins after treating deep vein thrombosis (DVT). This study focuses on patients with DVT symptoms lasting up to 14 days before the recanalization procedure. The goal is to find out if reducing local inflammation helps prevent blood vessel re-blockage and improves symptoms for up to 24 months after the initial procedure. Participants will be assigned to receive either perivascular dexamethasone or a saline sham treatment delivered around the affected vein segments. The study involves acute femoropopliteal DVT patients who have undergone successful thrombus removal from the major femoropopliteal veins, possibly extending into the iliac veins. The treatments are given as part of a phase 2 clinical trial evaluating these two approaches. During the study, participants will be monitored for clinically relevant vein openness (primary patency) and prevention of post-thrombotic syndrome (PTS) over 6 months, along with tracking major adverse events within 30 days. Follow-up assessments will include questionnaires and visits over a 24-month period to evaluate symptom improvement and treatment safety.

Researchers are evaluating a medical procedure using a catheter called the Bullfrog Micro-Infusion Device to deliver an anti-inflammatory drug, dexamethasone sodium phosphate, around deep veins after removing blood clots in patients with iliofemoral deep vein thrombosis (DVT). The study focuses on people who have had DVT symptoms for at least 14 days but no more than 60 days before the clot removal. The goal is to determine if local anti-inflammatory treatment helps prevent the reformation of clots and improves symptoms for up to 24 months after the initial procedure. Participants receive either perivascular dexamethasone or a saline solution delivered around the affected vein segment using the catheter. This is a phase 2 study comparing these two treatments after successful recanalization of the target vein and includes patients who require stenting of the iliofemoral segment. The treatment is given locally at the time of vein recanalization. During the study, participants will be monitored for clot openness (primary patency) at 6 months and for any major adverse events within 30 days. They will undergo follow-up visits, complete questionnaires, and have ongoing evaluations to track symptoms and safety for up to 24 months. The study requires adherence to prescribed anticoagulant and antiplatelet medications as part of post-procedure care.

Researchers are evaluating the safety and effectiveness of the Artix Thrombectomy System in patients who have acute lower limb arterial occlusions. This study is a post-market, prospective, multicenter, single-arm trial focused on treating blockages in arteries below the groin area in adults aged 18 years and older with symptoms lasting 14 days or less. It targets native vessels sized between 3 mm and 8 mm and includes patients categorized under Rutherford categories I, IIa, or IIb. Participants will receive treatment using the Artix Thrombectomy System to remove arterial blockages in the lower limbs. This device-based therapy involves an endovascular approach to restore blood flow. The study includes monitoring immediately after the procedure and safety evaluation within 48 hours post-treatment to assess the device's performance and any related risks. During the study, participants will be closely observed for treatment effectiveness and safety outcomes. Researchers will collect data immediately after the procedure and monitor patients for any adverse events within two days. The participation requires informed consent, and follow-up assessments will help determine the device's impact on arterial occlusions in the lower limbs.

Researchers are evaluating the Thor system in adults aged 18 years and older who have new, untreated calcified blockages in the arteries of their legs due to peripheral artery disease (PAD). The study aims to determine whether the Thor system is safe and effective in treating these lesions. Patients often experience leg pain during walking or rest caused by reduced blood flow, and this trial focuses on treating these specific types of arterial blockages. Participants will receive treatment using the Thor laser atherectomy system, which involves using laser energy to remove calcified plaque and modify calcium in the affected leg arteries. The procedure includes x-ray imaging of the leg arteries, and doctors may also use additional treatments such as angioplasty balloons, drug-coated balloons, stents, or clot filters if needed. There is no comparison group in this study, so all participants undergo the treatment with the Thor system. Participants will have a screening visit before the procedure, including medical history review, physical exams, blood flow tests, blood tests, and pregnancy testing if applicable. After treatment, patients will be monitored until discharge or up to 24 hours if they remain hospitalized. Follow-up visits will occur at 30 days, 6 months, and 12 months after treatment to assess medical status, leg blood flow via tests and ultrasound, walking ability, quality of life, and any adverse events. The total participation time is about one year, with enrollment expected to take up to two years across multiple U.S. sites.

Researchers are evaluating the adjunctive effectiveness and safety of the TIVUS System in adults with hypertension. The study includes people with uncontrolled hypertension taking 0 to 2 different anti-hypertensive drugs, and those with controlled hypertension taking 1 to 2 anti-hypertensive drugs. Participants will stop their medications for a 4-week wash-out before the procedure and remain off medications for 2 months after the procedure. The study is international, multicenter, randomized, double-blind, and sham-controlled, aiming to assess treatment outcomes while participants are off medications initially and then resume medication if needed. Participants will be randomly assigned in a 2:1 ratio to receive either the TIVUS Renal Denervation System, which uses ultrasound energy to denervate renal sympathetic nerves via catheterization, or a sham procedure consisting of an angiogram. After 2 months, those with uncontrolled hypertension will restart medications following a protocol. Unblinding occurs at 6 months, and participants in the sham group with uncontrolled hypertension may cross over to the TIVUS procedure. All treated participants will be followed for up to 36 months. During the study, participants will undergo blood pressure monitoring to measure daytime ambulatory systolic blood pressure changes from baseline to 2 months post-procedure. Major adverse events will be tracked from baseline through 30 days and 6 months after the procedure. Assessments include blood pressure readings, renal imaging to confirm eligibility, and safety follow-up visits. Medication adherence, side effects, and procedural safety will be closely monitored throughout the study duration.