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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are collecting and evaluating clinical data on various Abbott vascular medical devices used for conditions such as acute myocardial infarction, coronary artery lesions, restenoses, venous embolism, and arterial embolism. This prospective, non-randomized, open-label, multi-center registry aims to confirm the safety and performance of these devices over their expected lifetime. The study also focuses on monitoring identified risks, detecting new risks based on actual evidence, ensuring the benefit-risk balance remains acceptable, and identifying any misuse or off-label use of the devices. Participants are grouped based on the type of device used in their vascular procedure. These devices include coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging tools FFR and OCT, peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closurecompression devices, and vascular access introducers. Each participant receives the device relevant to their treatment as part of their procedure. During the study, researchers track participants from the start of their procedure, defined as the time a guidewire first enters the vasculature, until vessel closure following the procedure. They monitor outcomes such as death, myocardial infarction, target lesion revascularization, device-related complications, and procedural success at various points including during the procedure, at 30 days, and at 12 months. Participants are expected to follow a specified follow-up schedule to provide data on device safety and performance throughout the study duration, which runs until November 2031.

Age: 18Years +All Genders
37 locations
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Actively Recruiting

This research aims to gather more information on the safety, effectiveness, and performance of the DynamX Coronary Bioadaptor System in treating patients with ischemic heart disease caused by new native coronary artery lesions. It focuses on a real-world patient population with coronary artery disease to confirm how well this device works and its safety when used in routine medical care. All participants in the study will receive at least one implant of the DynamX Novolimus-eluting Coronary Bioadaptor System during a percutaneous coronary intervention PCI procedure. The device will be used following the products instructions in a commercial setting. This registry monitors the devices performance and outcomes over time without altering the usual care process. During the study, patients will be followed to assess clinical outcomes such as device success, procedural success, and various cardiovascular events including myocardial infarction, revascularization, stroke, and death. These outcomes will be tracked at hospital stay, 30 days, and 12 months after the procedure. The study also collects data on the duration of dual antiplatelet therapy DAPT and will monitor device safety and effectiveness throughout the follow-up period, which extends up to 12 months and beyond.

Age: 18Years +All Genders
17 locations
P

Actively Recruiting

Researchers are collecting real-world data on the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System in patients who have undergone percutaneous coronary intervention PCI. This prospective, observational registry study involves up to 10,000 patients treated at up to 150 cardiology centers across Europe, South America, the Middle East, and Asia over five years. The study provides post-market clinical follow-up as part of ongoing post-market surveillance. Participants receive the BioFreedom Ultra device, which consists of a cobalt chromium stent platform coated on the outside with the active ingredient BA9, without polymer or carrier. The study observes the use of this device in standard clinical practice without altering patient care. Patients are monitored mainly through telephone or clinic visits one year after PCI. During the study, participants will be followed for 12 months to collect data on outcomes such as target lesion failure, clinically driven target lesion revascularization, cardiovascular death, target vessel myocardial infarction, target vessel revascularization, and stent thrombosis. Follow-up assessments are conducted primarily by phone, ensuring safety monitoring and data collection in a real-world setting with minimal disruption to participants routine care.

Age: 18Years +All Genders
10 locations
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Actively Recruiting

This research aims to collect real-world data on the characteristics, management, healthcare use, and outcomes of patients living with type 2 diabetes, hypertension, heart failure, and chronic kidney disease. It is an international observational registry that includes patients from many countries to better understand how these conditions are treated in everyday clinical practice. Participants in this registry are observed without receiving experimental treatments. Data are collected both retrospectively and prospectively using a cloud-based electronic case report form accessible to investigators and a scientific committee. The registry includes groups of patients with type 2 diabetes, hypertension, chronic kidney disease, or heart failure, either as their primary condition or as a coexisting condition. Patients provide information about their health status, treatments, and outcomes over time. Researchers collect data on demographics, disease characteristics, laboratory tests, treatments, healthcare visits, hospitalizations, and lifestyle factors. The study measures many outcomes such as blood sugar levels, kidney function, heart function, medication use, and health events over an average of three years. Participation is voluntary and ongoing, with data collection continuing until the study end date in 2030.

Age: 18Years +All Genders
76 locations
S

Actively Recruiting

Researchers are studying the effects of dupilumab treatment on mental health, specifically anxiety and depression symptoms, as well as quality of life in patients with moderate-to-severe atopic dermatitis AD. The study focuses on patients already receiving dupilumab, aiming to observe how this treatment impacts their psychological well-being and life quality over time. Participants will be observed during a 6-month period while continuing their dupilumab therapy as prescribed by their doctors in real-world clinical settings. The study does not administer any treatments but monitors patients who start dupilumab within 30 days before enrollment. The enrollment period for the study will last about 9 months. Throughout the study, participants will complete assessments measuring anxiety and depression levels using the Hospital Anxiety and Depression Scale HADS and quality of life via tools like the Patient-Oriented Eczema Measure POEM and Dermatology Life Quality Index DLQI. Researchers will evaluate changes from baseline to week 24 in these scores and monitor professional and psychological impacts. The study aims to better understand the mental health outcomes of patients receiving dupilumab over six months.

Age: 12Years +All Genders
7 locations