Dendermonde

Researchers are evaluating the safety and effectiveness of the Supera Vascular Mimetic Implant, a special stent designed to treat narrowed or blocked areas in the common femoral artery, compared to traditional surgical removal of artery plaque (endarterectomy). This study focuses on patients with Peripheral Arterial Disease classified as Rutherford category 2, 3, or 4. The goal is to see if the implant is at least as effective as surgery and possibly safer for patients. Participants are randomly assigned to one of two groups: one receiving the Supera stent through a minimally invasive procedure involving balloon dilation and stent placement, and the other undergoing standard surgical endarterectomy. The procedure involves crossing the lesion with a guidewire, angiographic assessment, and optional post-dilation for the stent group. The surgery group receives treatment according to standard care. Follow-up visits are scheduled at 1, 6, 12, 24, and 36 months after the procedure. Throughout the study, patients will undergo assessments including physical exams, walking ability questionnaires, blood tests, ankle and toe blood pressure measurements, and ultrasound imaging to check blood flow. Researchers will monitor for outcomes such as artery openness (patency), need for additional treatments, wound healing, and any adverse events up to 36 months. Primary outcomes focus on artery openness at 12 months and safety within 30 days post-procedure.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

The Abbott Vascular Medical Device Registry (AV-MDR) is a prospective, non-randomized, open-label, multi-center registry designed to collect and evaluate clinical data on various Abbott vascular devices. The study focuses on confirming the safety and performance of these devices throughout their expected lifetime, monitoring risks, detecting new issues based on actual evidence, and ensuring that the benefit-risk balance remains favorable. It also aims to identify any possible misuse or off-label use to verify appropriate device use in patients with conditions such as acute myocardial infarction, coronary artery lesions, restenoses, and embolisms. Participants receive one or more Abbott vascular devices including coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging devices such as fractional flow reserve (FFR) and optical coherence tomography (OCT), peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closure and compression devices, or vascular access introducers. The devices are used during planned or completed vascular procedures, with treatment and device types depending on the participant's medical needs and the study scope. Throughout the study, participants are monitored during the vascular procedure and followed up at multiple time points including during the procedure, at 30 days, and at 12 months. Researchers assess outcomes such as death, myocardial infarction, target lesion revascularization, amputations, device success, complications, and imaging quality. The study involves collecting data on device performance and safety events, ensuring adherence to follow-up schedules, and aims to provide comprehensive information on the long-term use and risks associated with Abbott vascular devices.

Researchers are evaluating the safety and effectiveness of the AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter compared to a standard non-coated PTA balloon catheter. This trial focuses on treating blockages in the infrapopliteal arteries—arteries below the knee and above the ankle—in patients with chronic limb-threatening ischemia (CLTI) classified as Rutherford category 4 or 5. The study aims to determine if the coated balloon provides better results and similar safety outcomes to the standard device. Participants will undergo treatment with either the AcoArt Litos coated balloon or the standard PTA balloon catheter. The study restricts treatment to blockages located between the P3 segment of the popliteal artery and the tibiotalar joint and requires successful pre-dilatation of the target lesion. The procedure will be performed following specific angiographic criteria, including vessel diameter and lesion length. Patients will not have prior surgeries or interventions within 2 weeks before or planned 30 days after treatment. During the study, participants will be closely monitored with follow-up evaluations to assess limb preservation and vessel openness at 12 months, as well as safety outcomes such as major adverse limb events and peri-operative death within 30 days. The study requires commitment to follow-up visits and adherence to study protocols, with measurements including angiographic assessments and clinical evaluations to determine the treatment’s impact over time.

Researchers are evaluating the safety, performance, and clinical benefit of the BeFlow Iliac Covered Stent System in patients with iliac artery stenosis or occlusion. This international, multi-center observational study aims to monitor the technical success of implanting the device, assess its clinical performance, and identify any potential unknown side effects related to its intended use. The study involves the endovascular treatment of narrowed or blocked iliac arteries through the permanent placement of a covered stent inside the affected blood vessel. The BeFlow device is implanted to restore and improve blood flow impaired by arteriosclerosis or other conditions causing artery narrowing. The treatment follows the instructions for use (IFU) of the BeFlow Iliac Covered Stent System. Participants will be monitored over time to evaluate the primary patency rate at 12 months, which measures how well the treated artery remains open. The study will collect data on the technical success of the stent implantation, clinical benefits experienced by patients, and any side effects that may arise. This observational approach allows researchers to understand the device's real-world performance and safety.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

This research focuses on patients with borderline resectable (BR) and locally advanced pancreatic ductal adenocarcinoma (LAPDA) undergoing neoadjuvant chemotherapy with FOLFIRINOX. The study aims to assess whether combining diffusion-weighted magnetic resonance imaging (DW-MRI), radiomics, and multi-omics profiling from liquid biopsies can better predict successful surgical removal of the tumor. It addresses the challenge that standard CT imaging and tumor marker CA 19-9 lack accuracy in predicting if surgery will be successful, potentially leading to unnecessary operations or missed treatment opportunities. Participants will receive standard care, including chemotherapy and routine CT imaging, along with additional DW-MRI scans and blood samples for advanced genetic and molecular analysis before and after chemotherapy. The study includes one treatment arm and uses specialized imaging and genetic tests to analyze tumor response and progression. If no tumor progression is detected and tumor markers decrease, patients will be considered for surgery, during which further blood samples will be collected to study circulating tumor cells. Throughout the study, participants will undergo imaging, blood tests, and complete questionnaires about their health and quality of life. Researchers will measure outcomes such as surgical resectability, cancer recurrence, and survival over two years. The study aims to refine surgical decision-making, reducing unnecessary surgeries and improving patient outcomes while monitoring safety and treatment responses for up to five years.

Researchers are evaluating a digital tool integrated into electronic health records to improve how clinical and patient-reported outcomes are recorded for men diagnosed with localized or locally advanced prostate cancer. The study focuses on using this technology for structured and prospective reporting over time to enhance quality of care. Participants will receive the standard care typically provided for prostate cancer without any additional study medications or procedures. Clinical outcomes will be documented through predefined electronic forms within the health record system, while patients will report their experiences electronically. Treatment choices remain under the control of the treating physician. During the study, participants will be followed for up to 10 years after diagnosis. Researchers will assess the consistent reporting of clinical parameters and patient-reported outcomes throughout this period. The study involves electronic data collection and monitoring to evaluate the quality and completeness of outcome reporting in routine care.

Researchers are evaluating the safety and clinical performance of the Oscar Peripheral Multifunctional Catheter in treating lesions in the femoral, popliteal, and infrapopliteal arteries. This observational study focuses on patients with peripheral arterial disease and aims to confirm procedural success rates and monitor in-hospital complications related to endovascular interventions. The study includes a wide range of patients undergoing standard care practices for these artery lesions. The treatment involves using the Oscar Peripheral Multifunctional Catheter, which includes three components: the Oscar Support Catheter with integrated Lock Grip, the Oscar Dilator, and the Oscar PTA Balloon. The balloon can also be used separately but only with the pre-supplied support catheter. The procedures target lesions located either above or below the knee, and certain vascular inflow lesions may be treated during the same procedure according to local standard care. Participants will be involved in the study by undergoing endovascular procedures using the catheter, with researchers monitoring procedural success defined by lesion crossing and residual stenosis under 30%, and absence of complications like vessel perforation or embolization. The study collects data on procedural outcomes and complications during hospital stay. The primary outcome measure is the success rate of the procedure using the Oscar device. Participants must be adults aged 18 or older and will be observed during their treatment and hospitalization period.