Endovascular Therapy

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 evaluating the safety and effectiveness of the Super-Bore 8/7F Thrombosis Aspiration Catheter in treating acute intracranial large vessel occlusion, a serious type of acute ischemic stroke. This randomized controlled trial compares this new catheter with commonly used thrombectomy devices to see which is better at removing blood clots and restoring blood flow in the brain. Participants are randomly assigned to one of two groups: one group receives mechanical thrombectomy using the Super-Bore 8/7F Thrombosis Aspiration Catheter, while the other group is treated with standard thrombectomy devices. The procedure is performed within 24 hours of stroke onset to remove the clot blocking major brain arteries. During the study, researchers will measure how often the first pass effect (successful clot removal on the first attempt) occurs within 5 minutes at the final angiography. They will also assess participants’ disability and recovery 90 days after the procedure using the modified Rankin Score. Participants will be monitored closely throughout to evaluate safety, treatment impact, and outcomes.

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.

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 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.

This research aims to observe and evaluate the outcomes of endovascular treatment for acute ischemic stroke (AIS) caused by vessel blockage in the brain's anterior or posterior circulation. The study is a prospective, multicenter, observational trial designed to assess the safety and functional recovery of patients receiving this treatment in routine clinical settings. Participants receive endovascular treatment, which may include mechanical thrombectomy using devices such as stents, aspiration catheters, or combinations with intra-arterial clot-dissolving therapies. The study records these procedures as part of standard care without randomization or comparison groups since it is observational. During the study, researchers will track patients' recovery and safety outcomes through various assessments, including a primary focus on functional improvement measured by the modified Rankin scale at 90 days. Additional measures include neurological status at 24 hours and 7 days, as well as details about blood vessel reopening immediately after and during the procedure. The study intends to provide insights into real-world treatment results and safety over the follow-up period.

Researchers are conducting a phase III, open-label, randomized controlled trial to compare two treatments after surgery for hepatocellular carcinoma (HCC) with narrow surgical margins and high-risk features. The goal is to assess which approach better prevents cancer recurrence and improves survival over a two-year period. This multicenter study evaluates adjuvant radiotherapy combined with the drug sintilimab against transarterial chemoembolization (TACE).

Researchers are evaluating the impact of adjuvant transarterial chemoembolization (TACE) on recurrence-free survival in patients with hepatocellular carcinoma (HCC) who have high-risk factors for recurrence after curative hepatectomy. This Phase III randomized controlled trial addresses the controversy over adjuvant TACE's effectiveness, comparing it to intensive follow-up alone. The trial aims to clarify if TACE reduces postoperative recurrence and improves overall survival, with safety and adverse events also monitored. Participants will be randomly assigned to one of two groups. The adjuvant TACE group will receive a single treatment involving embolization with lobaplatin and ethiodized poppyseed oil near the hepatic resection margin after surgery. The intensive follow-up group will undergo hepatic arteriography without embolization or chemotherapy. Both groups will have post-procedure care including catheter removal and hemostasis. During the study, participants will be closely monitored for recurrence through follow-up assessments. Researchers will measure recurrence-free survival over two years, overall survival, treatment-related adverse events, and the time to recurrence. The study includes careful evaluation of safety and treatment discontinuation rates, with the total participation spanning a period sufficient to capture these outcomes.