Lubin

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with stomach or gastroesophageal junction GEJ cancer. This study focuses on cancers that do not have the HER2 protein but do express Claudin 18.2. The goal is to understand how well zolbetuximab works with pembrolizumab and chemotherapy compared to a placebo with pembrolizumab and chemotherapy in people with advanced or metastatic disease that cannot be removed by surgery or has spread to other parts of the body. Participants will be randomly assigned to receive either zolbetuximab or a placebo, both given via intravenous infusion every 2 or 3 weeks, alongside pembrolizumab infusions every 3 or 6 weeks. Chemotherapy will be administered using one of two regimens, CAPOX or modified FOLFOX6, over multiple cycles lasting about 42 days each. Treatment continues until the cancer worsens, side effects prevent further use, or another therapy is needed. Pembrolizumab may be given for up to 2 years. During the study, participants will visit the clinic for infusions and health monitoring, including scans to check cancer status. Medical problems and treatment side effects will be recorded. After treatment ends, participants will continue to have regular health checks and scans every 9 to 12 weeks, along with phone check-ins every 3 months. The study will measure overall survival, disease progression, response rates, and safety over several years, with up to 72 months of follow-up for some outcomes.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating different treatments for patients with bifurcation coronary artery disease affecting vessels larger than 2.0 mm in diameter. This international, multicenter, randomized clinical trial includes patients needing percutaneous coronary intervention PCI for stable coronary artery disease or acute coronary syndrome. The study compares two types of drug-coated balloons Paclitaxel and Sirolimus with new generation drug-eluting stents DES to assess their effects on bifurcation lesions. Participants will be randomly assigned to one of three groups Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons, or standard treatment with new generation drug-eluting stents. After successful lesion preparation, the assigned device will be used following standard coronary angioplasty procedures. The study is open-label, meaning both patients and doctors know the treatment given. The research team follows international guidelines and local practices during the procedure. During the study, participants will have follow-up assessments including CT-FFR or invasive FFR at 6 to 9 months to measure artery narrowing at the treated bifurcation. Additional outcomes such as major adverse cardiac events, cardiac and all-cause death, myocardial infarction, vessel revascularization, thrombosis, and bleeding are monitored up to about 24 months. Patients will be evaluated regularly to track safety and the effectiveness of the treatments over time.

Researchers are analyzing outcomes from patients who underwent percutaneous coronary intervention PCI for coronary artery disease involving bifurcation lesions. The study compares two different two-stent techniques the Culotte technique and the Double Kiss DK Culotte technique. This retrospective study uses data collected from two high-volume cardiac centers in the Lower Silesia Region between April 2012 and January 2024. The choice of which stent technique to use was made by the treating physician based on clinical and angiographic factors, with no restrictions on lesion characteristics. Patients included had bifurcation lesions treated with either the classical Culotte technique or the DK-Culotte technique, which involves an additional balloon dilation step after side branch stenting. The study groups consist of patients treated with one of these two stenting methods. The PCI was performed following standard clinical indications, with all patients informed about treatment options and risks before consenting. Patients who had previous stenting of the same bifurcation lesion before the procedure were excluded. Participants outcomes are monitored retrospectively over a 5-year period following their initial hospital stay. The primary outcome measured is target lesion failure, with evaluations every 6 months after hospital discharge. Secondary outcomes include major adverse cardiac events MACE. This long-term follow-up allows researchers to assess the safety and effectiveness of the two-stent techniques over time using clinical records and data analysis.

This research involves patients with chronic disabling refractory angina pectoris classified as Canadian Cardiovascular Society CCS classes 2-4. These patients have persistent angina despite receiving the maximum tolerated anti-angina medical therapy and are not suitable for percutaneous or surgical revascularization. The study aims to evaluate the long-term safety and effectiveness of the Coronary Sinus Reducer device in this group of patients through a single-center, single-arm registry. Participants undergo implantation of the Coronary Sinus Reducer, a balloon-expandable, hourglass-shaped scaffold that is placed percutaneously into the coronary sinus via the venous system. This device narrows the coronary sinus to delay blood outflow. After implantation, patients receive a follow-up visit one month later, then clinical assessments every six months over an observation period extending up to five years. During the study, participants will have initial evaluations including medical history, clinical assessment of angina severity by CCS class, Seattle Angina Questionnaire scores, a 6-minute walk test, and echocardiography. The main outcomes measured will be the reduction in angina symptoms one year after device implantation. Secondary outcomes include adverse events, changes in aerobic capacity and endurance, and improvement in quality of life. Clinical follow-up will continue for up to five years to monitor safety and efficacy.

This research focuses on patients with moderately to severely calcified lesions in their coronary arteries who undergo percutaneous coronary intervention PCI. The study aims to collect data on the safety and effectiveness of PCI when supported by the Orbital Atherectomy Device. Patients are selected based on clinical indication according to current European Society of Cardiology guidelines and the presence of significant calcification assessed by angiography or intravascular imaging techniques like IVUS or OCT. The study involves patients treated at two cardiac centers in Poland where the decision to use the Orbital Atherectomy Device during PCI is made by the operator based on lesion characteristics. Moderate calcification is defined as involving 30% to 50% of the lesion diameter, while severe calcification involves more than 50%. The procedure details, including additional lesion preparation, stent implantation, medication, and imaging use, are determined by the treating physician. All patients give informed consent after being advised about treatment options and risks. Participants will be monitored at discharge up to 10 days to assess clinical success and any treatment-emergent adverse events. Long-term follow-up includes evaluation of major adverse cardiac and cerebrovascular events for up to five years after hospitalization, with assessments every six months. The study collects comprehensive data on treatment outcomes and safety during and after the procedure, supporting ongoing patient care and research.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction MI specifically ST-segment elevation MI STEMI or non-ST-segment elevation MI NSTEMI who also have multivessel coronary artery disease CAD and have undergone successful treatment of the culprit lesion with Percutaneous Coronary Intervention PCI. The study aims to compare physiology-guided complete revascularization to angiography-guided complete revascularization, focusing on both efficacy and safety outcomes. Participants are randomly assigned to one of two groups. One group receives physiology-guided PCI where the function of non-culprit lesions NCLs is assessed using resting full-cycle ratio RFR or fractional flow reserve FFR, with PCI performed on lesions meeting specific thresholds. The other group undergoes angiography-guided PCI, receiving routine staged PCI on all qualifying NCLs identified before randomization. Both approaches follow local practice standards for PCI. During the study, researchers monitor participants for a minimum of two years to assess the time to first occurrence of major cardiovascular events, including cardiovascular death, new MI, or ischemia-driven revascularization, as well as safety outcomes like significant bleeding, stroke, stent thrombosis, or kidney injury related to contrast use. The trial also includes an observational imaging study using optical coherence tomography in a subset of patients. Follow-up assessments will enable evaluation of both efficacy and safety over the study period.

Researchers are evaluating the safety, effectiveness, and clinical outcomes of percutaneous coronary intervention PCI for chronic total occlusions CTO in patients treated in routine clinical practice in Poland. The study seeks to understand procedural success rates, complications, and how different PCI strategies, intravascular imaging, mechanical support, and artificial intelligence analysis impact patient outcomes and quality of life. It also focuses on outcomes in various patient subgroups, including those with complex medical histories. This observational study enrolls patients undergoing CTO PCI as part of their standard care in a national, multicenter registry. Clinical, procedural, and follow-up data are collected prospectively to assess real-world outcomes. The study compares PCI performed with and without intravascular imaging and evaluates different treatment strategies such as drug-coated balloons, drug-eluting stents, and hybrid approaches. It also monitors the use of mechanical circulatory support and applies AI-based analysis of baseline electrocardiograms for outcome prediction. Participants will be followed to measure technical success of the procedure and monitor procedural details such as procedure time, fluoroscopy time, radiation dose, contrast volume, and procedural complications within one day. Additional outcomes include target lesion failure during hospital stay and up to one year, as well as mortality at one year. The study collects information on post-procedure cardiac injury markers and quality-of-life improvements, with data gathered throughout routine clinical care over the follow-up period.

Researchers are evaluating the safety and clinical performance of the Freesolve 35- and 40-mm resorbable magnesium scaffold system for treating patients with long de novo coronary artery lesions up to 38 mm in length. This international, multi-center, single-arm trial focuses on subjects with symptomatic coronary artery disease eligible for percutaneous coronary intervention PCI and aims to support CE certification of these scaffold sizes. The primary outcome is the rate of Target Lesion Failure at 12 months, with follow-up continuing up to five years. Participants will receive implantation of the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System Freesolve with scaffold lengths of 35 or 40 mm. The treatment is a device-based intervention intended for use in native coronary arteries with specific lesion characteristics. All subjects will be followed for up to 60 months post-procedure, with clinical visits scheduled at 1, 6, 12, 36, and 60 months. Additionally, a pharmacokinetic substudy will enroll 15 patients to study sirolimus drug levels using blood samples collected up to seven days after scaffold implantation. During the study, participants will undergo assessments at scheduled follow-up visits to monitor safety and clinical outcomes related to the scaffold implantation. Data will be collected on the occurrence of target lesion failure and other clinical events. Participants are expected to comply with study visits and treatment protocols, including dual antiplatelet therapy. The total study duration is approximately six and a half years, including a 15-month recruitment phase and a five-year follow-up period.