Interventional Radiology

Researchers are studying patients with elevated Lipoprotein(a) levels above 30 mg/dL who have undergone percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation but have not experienced cardiovascular events or significant bleeding within 12 months after the procedure. The trial aims to compare whether extending dual antiplatelet therapy (DAPT) from the standard 12 months to 24 months can reduce major adverse cardiovascular and cerebrovascular events such as death, heart attack, and stroke. This randomized, double-blind trial also evaluates if longer DAPT is as safe as the standard duration regarding bleeding and net adverse clinical events. Participants are randomly assigned to one of two groups: one group receives aspirin combined with clopidogrel for 24 months after PCI, while the other group receives aspirin plus a placebo identical to clopidogrel for 12 months. The therapy is delivered as oral medications daily. The study includes a follow-up period with assessments at 3, 6, 9, and 12 months after randomization to monitor outcomes. The trial is conducted across multiple centers with blinded evaluation of results. During the study, participants will undergo regular monitoring to assess cardiovascular events and bleeding incidents, including all-cause death, myocardial infarction, stroke, stent thrombosis, and various bleeding types classified by the Bleeding Academic Research Consortium. Data will be collected through clinical visits and evaluations at predefined intervals up to 12 months after randomization. The research team will analyze these measures to determine the efficacy and safety of extended DAPT in this high-risk population. The total study duration includes treatment and follow-up phases to ensure comprehensive outcome assessment.

Researchers are studying patients with acute coronary syndrome who undergo percutaneous coronary intervention to understand the risk factors that affect the occurrence and prognosis of this condition. This observational study will follow participants for at least two years to track major adverse cardiovascular events, including all-cause mortality, cardiovascular mortality, and ischemic stroke. The study is led by Su Guohai and aims to gather comprehensive data to improve knowledge about acute coronary syndrome outcomes. Participants will have blood and fecal samples collected for detailed analysis. Clinical information such as diagnosis, medical history, lab test results, treatment methods, prognosis, and follow-up data will also be recorded. The study focuses on monitoring the progression and outcomes of acute coronary syndrome over time through regular data collection. During the study, participants will be closely followed up to document any major cardiovascular events over a two-year period and beyond. Researchers will assess various health measures and risk factors to better understand how acute coronary syndrome develops and progresses. The total duration of participation includes initial enrollment and ongoing observation to capture long-term outcomes.

Researchers are developing and validating an artificial intelligence (AI) model to predict treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) who have undergone transcatheter device closure. This observational study aims to determine if combining information from demographics, lab results, health records, echocardiography, chest X-rays, and electrocardiograms can accurately assess individual risk of complications within 30 days after the procedure. The study uses retrospective clinical data from pediatric patients treated at a single center. The AI model will be trained using deep learning techniques to analyze various types of clinical data, including text and images, collected from routine care records. The study does not involve any new treatments or interventions but focuses on data integration and AI prediction methods. The primary outcome is the occurrence of procedure-related complications within 30 days after the transcatheter closure. Participants are children aged 18 years or younger who had a confirmed diagnosis of pmVSD and underwent transcatheter device closure at the study center. Researchers will review medical records to gather necessary clinical and imaging data. The study evaluates the AI model's performance in predicting complications using metrics such as precision-recall curves, sensitivity, and predictive values, all within 30 days after the procedure. The study is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, and is planned to end in June 2026.

Researchers are evaluating microwave ablation (MWA) as a minimally invasive treatment option for patients with relapsed Graves' disease who have previously been treated with anti-thyroid drugs but experienced a return of symptoms. Graves' disease is the most common cause of hyperthyroidism, and conventional treatments include anti-thyroid drugs, radioiodine, and surgery. However, these treatments have drawbacks such as side effects, risk of worsening eye symptoms, or surgical complications, which has led to interest in alternative therapies like MWA. In this study, all participants will receive ultrasound-guided MWA treatment using a device that inserts a microwave antenna into the thyroid gland to apply thermal energy and ablate the tissue. The procedure targets the entire thyroid gland, including both lobes, the isthmus, and the pyramidal lobe. This approach avoids surgical scars and preserves the organ, and it is performed as an outpatient procedure. The study does not involve comparison groups but focuses on evaluating this treatment. During the study, participants will be monitored for remission of Graves' disease six months after the procedure. Researchers will also measure changes in quality of life and thyroid gland volume at six months. The study includes follow-up assessments to evaluate treatment outcomes and safety. Participants can expect clinical evaluations and ultrasound examinations as part of their involvement. The total participation duration extends at least six months post-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 device's 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.

Researchers are studying patients with papillary thyroid carcinoma (PTC) who have undergone thermal ablation at a hospital since February 2023. The study aims to analyze factors that may influence the recurrence of PTC after this treatment. Data collected include demographic information, ultrasound results, laboratory tests, and thyroid disease-related scales measuring fatigue, depression, and stress. The study involves no additional interventions beyond the thermal ablation already received by participants. Ultrasound and pathology are used to confirm diagnosis and characteristics of the thyroid nodules before treatment. Follow-up occurs for one to five years to observe the recurrence of PTC. Participants provide demographic and medical data before and after ablation. Researchers monitor recurrence using ultrasound and assess thyroid-related symptoms through questionnaires. The primary outcome measured is the rate of PTC recurrence over one to five years. The study is observational, with no experimental treatment assigned, and participants are monitored over time to better understand recurrence risks.

This research aims to evaluate the effect of injecting nicorandil directly into the coronary artery before percutaneous coronary intervention (PCI) in patients with coronary artery disease who have high-risk plaques. The study focuses on preventing a decrease in coronary blood flow, measured by the TIMI flow, during the procedure. Participants are patients requiring stent treatment with a high lipid core burden index at the main lesion site. Participants with a lipid core burden index above 353 are randomly assigned to one of two groups. One group receives an intracoronary injection of at least 8cc of nicorandil before balloon therapy during PCI. The other group undergoes the standard PCI procedure without the nicorandil injection. The stent treatment method follows the usual clinical practice in both groups. During the study, researchers will monitor the occurrence of decreased TIMI flow during the procedure as the primary outcome. Secondary outcomes include changes in cardiac biomarker levels one month after intervention and several patient health measures such as mortality, cardiac death, myocardial infarction, and revascularization rates over one year. The study involves clinical follow-up and written consent for data use from participants, with the total duration including at least one year of follow-up.

Researchers are investigating the mechanisms that sustain persistent atrial fibrillation (AF) and ventricular fibrillation (VF) in humans. This study focuses on understanding how specific areas of high-frequency electrical activity, called DFASI domains, maintain these heart rhythm disorders. The project aims to explore how targeting these domains with ablation therapy affects AF dynamics and clinical outcomes, and to extend these findings to improve treatment options for patients with recurrent VF. The study involves two groups: a control group receiving circumferential pulmonary vein isolation (CPVI) alone, and an active group receiving CPVI plus additional ablation targeting DFASI domains identified through non-invasive mapping. After CPVI in both groups, researchers will perform non-invasive mapping to assess fibrillation patterns, with the active group undergoing sequential ablation of the DFASI domains. Adenosine will be used to evaluate changes in fibrillation dynamics before and after ablation. Participants will undergo detailed non-invasive mapping during the procedure to identify reentrant areas with high activation frequency. Researchers will measure changes in fibrillation dynamics during and after ablation, and track arrhythmia burden over follow-up visits at 3, 6, and 12 months. The study includes safety monitoring and aims to improve understanding of fibrillation physiology and treatment effectiveness over time.

Renal cell carcinoma (RCC) is the most common type of kidney cancer and usually treated with surgery. However, for patients who cannot undergo surgery and have tumors larger than 4.0 cm, there is no established therapy. Researchers are evaluating Yttrium-90 (Y-90) radioembolization, a treatment delivering targeted internal radiation, to see if it can effectively treat these larger RCC tumors. This phase II study aims to assess the tumor response one year after treatment and monitor safety and kidney function over five years. Participants will receive Y-90 radioembolization using glass spheres injected into the arteries supplying their RCC tumors. This internal radiation aims to deliver a high dose directly to the tumor while minimizing exposure to nearby organs. The study focuses on patients with localized RCC larger than 4 cm who are not candidates for surgery or have declined it. The treatment will be given once, and participants will be followed for up to five years to assess long-term cancer control and safety. During the study, participants will undergo regular assessments including imaging scans at enrollment, 3 months, and 12 months post-treatment to measure tumor response. Kidney function will be monitored at multiple time points up to five years. Patient-reported outcomes will be collected shortly after treatment, and safety evaluations will be conducted throughout the follow-up period. The main outcome is tumor response at 12 months, with additional measures including adverse events, kidney function changes, and survival rates tracked over the five-year period.

Researchers are evaluating the Methinks Stroke Suite, an AI-based imaging software, to see if it can help speed up the transfer of acute stroke patients who may need thrombectomy from local stroke centers to specialized centers. The study focuses on patients initially assessed at centers that cannot perform endovascular therapy (EVT). The main goals are to find out whether the software reduces the time to decide on patient transfer and how accurately it identifies candidates for EVT. The study compares patient care after integrating Methinks Stroke Suite into the stroke workflow with a historical group treated before its use. Patients will have a CT scan analyzed by the AI software at the local center. If the software and clinical judgment suggest thrombectomy might be needed, patients are transferred to specialized centers. If no large vessel occlusion is detected, further imaging like CT angiography may be done to reassess. This is an open-label, quasi-experimental study conducted across multiple centers in Catalonia, Spain. Participants will undergo CT scans at their local stroke center, with imaging data processed by the Methinks software. They will be followed for 90 days after their stroke to assess recovery and functional outcomes. Researchers will measure time from arrival to transfer decision, evaluate the software's accuracy in detecting large vessel occlusions, monitor treatment rates, and gather clinician feedback on using the software. Safety during patient transfers will also be tracked. The study plans to enroll about 250 patients and includes a follow-up period of 3 months after stroke.