Clinical Research Directory

Endovascular Coiling Using Target Tetra® Coils for Small Intracranial Aneurysm

The goal of this study was to verify the safety and effectiveness of Target Tetra® Detachable Coil in the endovascular embolization treatment of small intracranial aneurysm (≤5mm).

The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).

The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.

Pivotal Study of the Silk Vista Baby Flow Diverters in the Treatment of Unruptured Intracranial Aneurysms (PIONEER)

The PIONEER Study is a pivotal, multi-center, prospective, single-arm study designed to evaluate the safety and efficacy of the Silk Vista Baby (SVB) Flow Diverter for the treatment of unruptured aneurysms.

Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment

The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial aneurysms. All patients with intracranial aneurysm ruptured or unruptured, whatever the localization of the aneurysm, and treated with silk vista or silk vista baby, will be consecutively enrolled in the study. The patient's inclusion and follow up in the study will occur as part of their usual standard of care.

A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms

The purpose of this study is to assess how safe choydar flow-directed mesh stent is and how well it works in the treatment of unruptured intracranial aneurysms (a condition in which a bulging blood vessel in the brain can burst and cause bleeding) in a real-world setting.

NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.

International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)

This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.

Product Surveillance Registry

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.

A Multicenter Prospective Study of New Flow Diverter Stent on the Treatment of Intracranial Aneurysms in China

Intracranial aneurysm, as a common cerebrovascular disease, has a variety of treatment methods, including surgical treatment and endovascular treatment. Among these treatment methods, flow diverters have attracted much attention due to their unique therapeutic principles. Flow diverters help promote thrombus formation within the aneurysm by altering the direction and dynamics of blood flow, thereby achieving the purpose of treatment. 1-5 Flow diverters such as the Pipeline™ device have been proven to be safe and effective for the treatment of intracranial aneurysms and have gradually been recognized as the preferred device for the management of intracranial aneurysms.

Neurovascular Product Surveillance Registry

Post market surveillance registry

Surveillance Versus Treatment of Unruptured Intracranial Aneurysms of Fortuitous Discovery

The goal of this clinical trial is to determine whether a watchful waiting strategy with imaging surveillance is superior to immediate aneurysm treatment in adults with incidentally discovered unruptured intracranial aneurysms (UIAs). The main questions it aims to answer are: * Does watchful waiting reduce the risk of clinically significant neurological disability compared with immediate treatment? * How do the two strategies compare in terms of aneurysm rupture, treatment-related complications, quality of life, anatomical outcomes, and healthcare costs? Researchers will compare two management strategies: * Immediate selective treatment of the aneurysm (endovascular or neurosurgical treatment according to standard practice). * Watchful waiting with regular clinical and imaging follow-up and no initial aneurysm treatment. Participants will: * Be randomly assigned to either immediate treatment or watchful waiting. * Undergo routine clinical assessments and annual brain imaging for at least 42 months. * Complete quality-of-life questionnaires (EQ-5D-5L) at baseline and annually during follow-up. * Participate in annual telephone follow-up assessments, including evaluation of functional outcome using the modified Rankin Scale (mRS). * Undergo a blood or urine pregnancy test at enrollment if they are women of childbearing potential. The study includes adults aged 35 years or older with incidentally discovered, non-infectious, intradural saccular UIAs measuring between 2.0 mm and 7.9 mm and no history of subarachnoid hemorrhage. The primary objective is to compare the impact of the two management strategies on neurological dependency during follow-up.

Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms

The study is designed to evaluate the safety and effectiveness of ENTERPRISE 2 vascular reconstruction device and delivery system (hereinafter referred to as ENTERPRISE 2) to facilitate endovascular coil embolization of intracranial aneurysms.

General Anesthesia vs Local Anesthesia for Endovascular Treatment in Patients With Unruptured Intracranial Aneurysm Using Flow Diverter

The prevalence of unruptured intracranial aneurysm (UIA) in the population is about 2%-7%, and once it ruptures and bleeds, the rate of disability and death is extremely high, with 10%-15% of patients dying suddenly before they can seek medical attention, 35% of first-time bleeders, and 60%-80% of second-time bleeders. Survivors are often disabled. Therefore, there is a broad consensus that UIA with surgical indication should be aggressively intervened. The efficacy and safety of flow diverter (FD) in the treatment of UIA has been confirmed by many large clinical trials. Currently, FD placement for UIA is performed under general anesthesia (GA) in most centers, however, some studies have observed that FD placement under local anesthesia (LA) is not as effective as FD placement under general anesthesia and have demonstrated the feasibility of FD placement under local anesthesia (LA) with high technical success rates and low perioperative complication rates and mortality. However, the retrospective design and relatively limited sample size of the above studies may introduce significant bias and affect the confidence of the conclusions. Therefore, the present trial was designed as a randomized controlled trial with the aim of comparing the safety and efficacy of GA and LA in UIA patients undergoing FD placement. The results of this study will help inform future multicenter trials to validate the impact of anesthesia choice on the safety and efficacy in UIA patients undergoing FD placement.

Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.

This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.

INSPIRE Pipeline™ Shield Post Approval Study

The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex Embolization Device with Shield Technology™ ("Pipeline™ Shield Device") in a real-world post approval setting within the United States.

Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization

This prospective, multicenter, observational registry study will evaluate the real-world safety, effectiveness, and clinical value of artificial intelligence (AI)-assisted microcatheter shaping during coil embolization of intracranial aneurysms. Adults with an intracranial aneurysm who are scheduled to undergo coil embolization will be enrolled and followed for approximately 12 months. The study will not assign participants to a treatment strategy. All treatment decisions will be made by the treating physicians according to routine clinical practice. Participants will be analyzed according to whether microcatheter shaping is performed based on the physician's experience alone or with assistance from an intelligent microcatheter shaping simulation technology. The study will evaluate major adverse events within 12 months, immediate aneurysm occlusion after the procedure, clinical and quality-of-life outcomes, follow-up imaging findings, serious adverse events, repeat treatment or rehospitalization, microcatheter delivery performance, and health care resource use. At least 1,438 participants are planned to be enrolled.

Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation

This is an investigational study for a new medical device called the nOCT (neuro optical coherence tomography) Imaging System, which is manufactured by Spryte Medical, LLC. The nOCT Imaging System takes pictures from inside a blood vessel in your brain. These pictures give your doctor information about the inside of your blood vessel including the disease and any implanted devices. The nOCT Imaging System consists of a probe and a console. The probe is a small, flexible wire-like device designed to navigate through catheters which have already been inserted in your body as part of your planned procedure. Catheters are small, flexible, tubes inserted in your blood vessels which allow your doctor to deliver treatments such as medications, coils, or stents directly to the affected area. The console is a unit that includes a computer, screen and laser light source. The probe is connected to the console. The console provides the probe with low-power light from the laser which is used to scan and create pictures of your blood vessel. The pictures are displayed on the screen of the console for review by your doctor and may be stored for future viewing. The objective of the study is to evaluate the safety and effectiveness of the nOCT Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up.

Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.

Clinical Performance Evaluation of RDX-Aneurysm for Detecting Intracranial Aneurysms on TOF-MRA

This retrospective, multi-center, observational case-control study evaluates the standalone performance of RDX-Aneurysm, a computer-assisted detection software, for detecting and marking suspected saccular intracranial aneurysm locations on adult head time-of-flight magnetic resonance angiography (TOF-MRA). Approximately 550 evaluable examinations will be included, consisting of approximately 250 positive examinations with at least one reference-standard-confirmed saccular intracranial aneurysm measuring 3 mm or greater and approximately 300 negative examinations with no reference-standard-confirmed intracranial aneurysm. The primary outcome is lesion-level sensitivity for detecting reference-standard-confirmed saccular intracranial aneurysms measuring 3 mm or greater. The secondary outcome is false positives per scan. This study uses existing retrospective imaging data only; study outputs are not returned to clinical care and do not affect patient diagnosis, treatment, or follow-up.

Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment

We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component. The study will include patients with IAs treated with commercially available WEB devices under the direction of treating physicians in routine clinical practice. Clinical, procedural, imaging, and safety data will be collected using a standardized electronic data capture system, with safety events adjudicated by an independent clinical events committee and imaging outcomes assessed by an independent core laboratory. The primary objective is to evaluate 12-month adequate aneurysm occlusion and major adverse events after WEB treatment. The study is expected to provide comprehensive post-market evidence on the real-world performance of the WEB device in China, including its safety, effectiveness, clinical appropriateness, and health economic value in routine neurointerventional practice.

Trenza Embolization Device for Intrasaccular Aneurysm Treatment

The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.

Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping

Endovascular procedures for treating brain aneurysms and arteriovenous malformations (AVMs) are becoming increasingly popular due to their less invasive nature and lower risk of complications. However, they still face challenges such as difficult catheter navigation and incomplete embolization. This study aims to improve the efficiency and safety of endovascular procedures by developing new preoperative planning methodologies. These methodologies involve mapping the cerebral vasculature and creating computational fluid dynamics (CFD) and artificial intelligence (AI) models to simulate blood flow. By using these models, interventional radiologists can better plan catheter navigation and predict embolization outcomes. This could lead to faster, more accurate procedures with reduced radiation exposure for patients.

Evolve China PMCF Study

A prospective, multi-center, single-arm, open-label, observational, post-market clinical follow-up. The expected duration of the study is 8 years (including up to 5-years' follow-up). Each subject will be followed up per standard of care (SoC) at each study site.