Carotid Artery Disease

Carotid artery plaque rupture is a leading cause of ischemic stroke, and early, accurate assessment of plaque vulnerability can help prevent these strokes. Researchers are studying the use of 18F FDG and 68Ga-FAPI PETMR imaging to investigate features of vulnerable carotid plaques, such as active fibrosis and inflammation, which may better identify unstable plaques compared to standard MRI alone. This observational study aims to clarify imaging characteristics linked to plaque instability in patients with carotid artery plaques. Participants will undergo 18F FDG and 68Ga-FAPI PETMR scans to assess metabolic and structural plaque features. Treatments such as medication, carotid stenting, or carotid endarterectomy will follow clinical guidelines but are not assigned by the study. The study focuses on evaluating plaque vulnerability through advanced imaging rather than testing specific treatments. During the study, participants will be monitored for stroke and cerebral hemorrhage at 1, 6, and 12 months after their PETMR scan. Researchers will also assess the openness of the carotid artery lumen patency rate and analyze imaging results at these same time points. This approach aims to track plaque changes and clinical outcomes over one year to better understand plaque behavior and risk.

Atherosclerotic plaques, which are fatty build-ups in arteries, can develop silently and may rupture, leading to serious cardiovascular events like heart attacks or strokes. Despite treatments and controlling risks such as diabetes and high blood pressure, some people still develop dangerous forms of the disease. Researchers have found that plaques with thin caps, soft centers, or tiny new blood vessels are more likely to rupture, so new imaging methods are being developed to detect these vulnerable plaques earlier. This study evaluates a new 3D ultrasound probe and machine that can capture many more images than standard probes to visualize the entire plaque and its tiny blood vessels more accurately. Patients will receive an infusion of a microbubble contrast agent called SonoVue to enhance imaging. Initial 2D ultrasound images will confirm plaque presence, followed by 3D imaging using a specialized row-column array probe manipulated by a clinician. The 3D scan takes about 2 to 5 minutes and captures multiple images to assess plaque neovascularization. Participants will undergo ultrasound scans of their carotid arteries after receiving the contrast agent via an infusion. Researchers will analyze these images offline to detect new blood vessels within plaques. The main measurement is the detection of carotid plaque neovascularization at baseline. The study begins with consenting patients who have carotid plaques confirmed by previous CEUS scans. Participation involves imaging procedures and consent, with the study lasting as long as these assessments are completed.

Researchers are evaluating the use of 18FAlF-NOTA-octreotide PETMRI to study inflammation in carotid artery plaques in patients who recently had a stroke or transient ischemic attack TIA in the carotid artery area. This study aims to see if the tracer uptake in affected and unaffected carotid arteries can predict future cerebrovascular events such as recurrent TIA, stroke, or other vascular problems. The trial is conducted as a Phase 2 study at University Hospitals Leuven and focuses on patients with at least 30% stenosis in the carotid artery. Participants receive a single intravenous injection of the radioactive tracer 18FAlF-OC, dosed at 4 MBqkg, followed by a saline flush. The study has two parts in the first, five patients undergo PETMRI scans at 60, 120, and 180 minutes after injection to refine the imaging protocol. In the second part, nineteen patients receive PETMRI at the optimal time point identified earlier. Both the symptomatic culprit and non-symptomatic carotid arteries are scanned. Participants will have a screening and baseline assessment, followed by the PETMRI imaging visit. They will be contacted by telephone for follow-up interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA. Researchers will measure the standardized uptake values SUV of the tracer in the carotid arteries as the primary outcome. Secondary outcomes include the prediction of recurrent cerebrovascular events, major cardiovascular events, and overall mortality during the three-year follow-up period.

Researchers are evaluating the safety and early effectiveness of an injectable drug called IMC-001 in improving the stability of atherosclerotic plaques in patients diagnosed with acute coronary syndrome ACS, which includes conditions like acute myocardial infarction or unstable angina. This early phase 1, randomized, double-blind, placebo-controlled study is being conducted at two centers and aims to better understand how IMC-001 affects plaque stability in these patients. The study involves two dose groups with nine subjects each, where six receive IMC-001 plus optimal medical therapy and three receive a placebo plus optimal medical therapy. Participants will receive injections of either IMC-001 or placebo alongside standard treatments for coronary artery disease. The trial includes a dose escalation design to assess safety and preliminary efficacy. Participants will be monitored for changes in coronary artery low-attenuation plaque volume using coronary computed tomography angiography CCTA at baseline and again six months after treatment. The study will track safety, plaque volume changes, and other clinical assessments during the treatment and follow-up periods. The total participation duration includes the treatment phase and a six-month evaluation after dosing to assess the primary outcome measure.

Researchers are studying patients with carotid artery stenosis to compare the effects of ultra-intensive lipid-lowering therapy using a PCSK9 inhibitor combined with rosuvastatin or atorvastatin, with or without ezetimibe, against conventional lipid-lowering therapy using rosuvastatin or atorvastatin, with or without ezetimibe. The study aims to evaluate changes in the atherosclerotic plaque burden in these patients. Participants will either receive a combination of PCSK9 inhibitor injections every two weeks plus rosuvastatin or atorvastatin with or without ezetimibe, starting on the day of randomization, or they will continue or initiate treatment with rosuvastatin or atorvastatin with or without ezetimibe alone. The study is observational and involves two groups one exposed to the PCSK9 inhibitor plus statin treatment and the other receiving statin therapy alone. Throughout the study, participants will be monitored for changes in plaque burden at the most narrowed carotid site after about 180 days. Other assessments include lipid profiles, liver function tests, creatine kinase levels, plaque characteristics, and the occurrence of major vascular events up to 365 days. Researchers will also evaluate functional status using the modified Rankin Scale. The trial is expected to conclude in June 2027 with ongoing monitoring during the study period.

Researchers are evaluating the efficacy and safety of intravenously administered YN001 in adults diagnosed with coronary atherosclerosis who are also receiving background therapy for managing cardiovascular risk factors. This multinational, multicenter, phase 2b clinical trial is randomized, double-blind, and placebo-controlled to compare YN001 with placebo in this patient population. Participants will be randomly assigned to receive one of three doses of YN001 or matching placebo intravenously once weekly for 13 weeks. The doses include 40mg, 20mg, or 0mg placebo. The study consists of up to a 12-week screening and baseline period, a 12-week blinded treatment period, a 30-day safety follow-up, and a long-term follow-up extending to approximately two years after randomization. During the study, participants will undergo various assessments including imaging to measure changes in coronary non-calcified plaque volume, carotid intima-media thickness, and plaque characteristics at multiple time points. Safety and immunogenicity will be monitored alongside pharmacokinetic analyses. The primary outcome focuses on relative change in coronary NCPV at week 13. Participants will be followed for up to 96 weeks to evaluate major adverse cardiac events and long-term safety.

This study focuses on patients with coronary artery disease CAD who are undergoing or scheduled for percutaneous coronary intervention PCI. It aims to understand how common and significant head and neck arterial narrowing stenosis is in these patients. Researchers will explore how different combined treatment approaches affect patient health, using real-world data to improve care for those with both heart and brain blood vessel diseases. The study observes three patient groups those receiving both PCI and carotid artery treatment, those who have PCI with no or untreated carotid stenosis, and those managed with observation only without PCI or carotid intervention. Doppler ultrasound is used as the main screening tool to assess artery narrowing. Patients are followed under their usual care without additional experimental treatments. Participants will have their artery conditions checked at baseline, with health outcomes tracked over time through measures like the modified Rankin Scale mRS and rates of cardiovascular and cerebrovascular events. These assessments occur shortly after treatment and continue for up to a year to monitor both short- and long-term complications. The total duration depends on the follow-up period after initial hospitalization and treatment.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the devices performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.

The trial investigates the use of the CGuard Prime Carotid Stent System combined with the ENROUTE Transcarotid Neuroprotection System during Transcarotid Artery Revascularization procedures. It focuses on patients with carotid artery stenosis who are at high risk for problems from carotid endarterectomy. The study is a prospective, multi-center, single-arm pivotal trial aiming to evaluate the acute device and technical success of this device combination. Participants will undergo the Transcarotid Artery Revascularization procedure using the CGuard Prime 80cm stent system alongside the FDA-cleared ENROUTE Neuroprotection System. The study will enroll a minimum of 50 pivotal patients, with an additional roll-in cohort possible. Patients are screened for eligibility before enrollment, and the study is not blinded. The procedure is done once, and follow-up assessments extend up to one year. During the study, participants will be monitored from enrollment through follow-up visits for up to one year. Researchers will assess acute device success and technical success, along with secondary outcomes such as procedural and treatment success, rates of death, stroke, myocardial infarction, stent thrombosis, and serious adverse events within 30 days and up to one year. The study emphasizes safety and effectiveness monitoring through regular follow-ups to evaluate these outcomes.

Researchers are evaluating the efficacy of selnoflast compared with a placebo in adults with atherosclerosis who are at high risk for major adverse cardiovascular events MACE and are currently receiving standard-of-care therapy. This Phase IIa study aims to assess how selnoflast affects vascular inflammation in this population. Participants will be randomly assigned to one of two groups one group will receive selnoflast orally twice a day for 12 weeks, while the other group will receive a matching placebo on the same schedule. The study uses a quadruple masking design to compare the effects of selnoflast and placebo over the treatment period. During the 12 weeks of treatment, participants will undergo assessments including imaging scans to measure vascular inflammation, blood tests for drug concentration, and monitoring for adverse events. The primary outcome is the change in a vascular inflammation measure called mdsTBR in a target blood vessel from baseline to week 12 in participants with elevated baseline inflammation levels. Safety and pharmacokinetics will be followed up to about 20 weeks. Overall participation lasts up to approximately 6 months.