Davenport

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.

This research collects data and biological samples from patients who have experienced side effects from immunotherapy treatments for cancer. The goal is to create a national collection of these samples and clinical information to help future studies understand, predict, prevent, and treat serious immune-related side effects, rare infections, or rapid tumor growth after immunotherapy. Participants provide tissue and blood samples when they join the study and again one month later. Some patients may also provide stool samples if they have certain side effects like colitis. Researchers also review participants' medical records for up to one year to gather detailed health information related to their treatment and side effects. During the study, patients undergo sample collections and have their health records examined. The main outcome measured is the establishment of a national biorepository containing these samples and data, which will be used in future research over the course of one year. This study aims to support better understanding and management of immunotherapy side effects in cancer treatment.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating the safety and effectiveness of the FastWire System in patients who have chronic total occlusion (CTO) in the arteries of their lower limbs, which causes poor blood flow and ischemic limbs. This pivotal, single-arm, multi-center study plans to enroll up to 65 participants with severe claudication or critical limb-threatening ischemia (CLTI) to assess whether the FastWire System can successfully assist in placing guidewires or treatment devices through blocked peripheral arteries. During the procedure, investigators will use the FastWire System to cross the CTO caps or multiple lesions in the affected arteries below the origin of the superficial femoral artery, either above or below the knee. Participants must have angiographic confirmation of a de novo CTO with a total length less than 40 cm and at least one patent runoff vessel if the CTO is below the knee. The study does not include a comparison group and focuses on the performance of this device in real-world clinical settings. Participants will be closely monitored for clinical success on the day of the procedure and for freedom from serious adverse events up to 30 days afterward. The study involves detailed imaging assessments at the time of the procedure and ongoing safety evaluations. Overall participation will cover the procedure day and follow-up through the first month to assess initial safety and efficacy outcomes related to the FastWire System.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for treating infrapopliteal lesions in patients with critical limb ischemia (CLI). The study compares the MOTIV device to plain balloon angioplasty to assess safety and effectiveness. This randomized controlled trial aims to address symptomatic CLI classified as Rutherford category 4 or 5. Participants will receive either the MOTIV Sirolimus-Eluting Bioresorbable Scaffold or undergo percutaneous transluminal angioplasty (PTA) as treatment. The devices target native infrapopliteal artery lesions with specific size and length criteria. Treatment involves placing up to a maximum number of scaffolds per lesion and ensuring proper vessel flow without blocking major branches. Successful treatment of inflow artery lesions may be performed before or during the main procedure. During the study, participants will be monitored for limb salvage and vessel patency over six months. Safety is assessed by tracking major adverse limb events and death within 30 days after the procedure. Patients will undergo angiographic evaluations and follow-up assessments to measure outcomes, treatment success, and adverse events. The study requires adherence to protocol procedures and informed consent before participation.

This research aims to evaluate the effectiveness and usage of stent and non-stent therapies in patients with Peripheral Arterial Disease (PAD) who undergo endovascular interventions. The study focuses on comparing outcomes such as the need for further procedures, safety events including death or heart attack, and improvements in walking ability and symptoms over a 12-month period. It is designed as a large observational registry including data collected from January 2005 until 14,000 patients are enrolled across about 60 sites worldwide. Patients receiving either stents or percutaneous transluminal angioplasty (PTA) in specific leg arteries, including the superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries, are included. Those treated only in the external or common iliac arteries are generally excluded unless treated alongside these target arteries. Data collected includes patient background, lesion and procedural details, and follow-up clinical outcomes. Treatment decisions and follow-up visits are made according to routine clinical care and not mandated by the study. Participants’ data will be recorded at baseline and during follow-up visits at approximately 6 and 12 months after the initial procedure. The study collects information on walking ability, symptom severity, artery function tests, procedural success, and adverse events such as repeat interventions or amputations. Researchers will monitor outcomes to compare stent and non-stent therapies while ensuring minimal risk to patients as treatments follow standard clinical practice.

This research aims to evaluate the effectiveness and safety of a sirolimus drug coated balloon (DCB) compared to standard balloon angioplasty in treating below-the-knee arterial disease. This condition, part of peripheral arterial disease (PAD), can lead to limb loss, and while drug coated balloons have shown benefits in other arterial areas, their effectiveness below the knee is less clear. The study is a pivotal, prospective, randomized, single-blind, placebo-controlled trial conducted across approximately 80 sites worldwide, with a significant number of participants recruited from the USA, Europe, Australia, and Asia. Participants will first undergo standard balloon angioplasty to prepare the arterial lesion. They will then be randomly assigned to one of two groups: one receiving the MagicTouch PTA sirolimus coated balloon catheter in addition to the standard angioplasty, and the other receiving a placebo balloon angioplasty alongside the standard procedure. Lesions treated are in the below-the-knee arteries, and treatment will follow successful lesion preparation with less than 30% residual narrowing. During the study, participants will be monitored for primary patency at 12 months, defined as freedom from vessel blockage, restenosis, repeat interventions, and major amputation. Safety will also be assessed through a composite endpoint at 6 months and 30 days, depending on the measure. The trial includes detailed evaluations of arterial lesions and runoff, and will track outcomes to assess the potential benefits and risks of the sirolimus coated balloon in this patient population.