Diseases and Abnormalities at or Before Birth

All Conditions

Nervous System Diseases

Heart and Blood Diseases

Neoplasms

Rare Diseases

Congenital Abnormalities

Intracranial Arteriovenous Malformations

Arteriovenous Malformations

Hemangioma

Vascular Malformations

Cardiovascular Abnormalities

Vascular Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Central Nervous System Vascular Malformations

Nervous System Malformations

Intracranial Arterial Diseases

Intracranial Arteriovenous Malformation

Unsimultaneous endovascular interventional embolisation/radiotherapy followed by microsurgical resection, as traditional clinical routines.

A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously

A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.

hybrid operating techniques

To evaluate the clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations.

Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of cerebral arteriovenous malformations(AVMs). Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study.

Objects: Patients with cerebral arteriovenous malformations, coincident with inclusion and exclusion criterion and admitted in participating organizations.

Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional neurosurgical management or one-stage hybrid operating management correspondingly. Residual rate of AVM is considered to be the primary observing indicator, and morbidity rate of post-operative complications, post-operative mortality rate, and morbidity rate of neural functional deterioration are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.

Traditional therapy group：traditional management of AVMs, such as unsimultaneous endovascular interventional embolisation, radiotherapy followed by microsurgical resection, will be conducted to patients involved in this group.

Hybrid operation group: A one-stage hybrid operation combining endovascular intervention and microsurgical techniques will be conducted simultaneously to patients in this group.

Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room

The instant post-operative residual rate of AVMs

3 months' residual rate after AVM operation

6 months' residual rate after AVM operation

1 year's residual rate after AVM operation

Include intracranial hemorrhage or infarction, infection of central neural system, infection of respiratory system, cranial nerve deficits, and other symptomatic complications

The score of modified Rankin Scale increases ≥2

Beijing Municipal Science & Technology Commission

Ministry of Science and Technology of the People´s Republic of China

liuxingju

fMRI Navigation AVM resection in AVM patients

intraoperative fMRI navigation guided resection in AVM patients

fMRI Navigation AVM resection

conventional resection

Yong Cao, MD

Shuo Wang, MD

Little is known about the effect of fMRI navigation in the intracranial arteriovenous malformation surgery. The investigators aim to perform a multicenter prospective randomized single -blind clinical trial to assess the effect and safety of fMRI navigation in the brain arteriovenous malformation surgery.

Intracranial arteriovenous malformations (AVMs) are congenital lesions that consist of multiple arteries and veins, connecting as a fistula without an intervening normal capillary bed. Surgical removal is thought as a major treatment option for AVMs. However, compared with stereotaxic radiosurgery and endovascular embolization, microsurgery of AVMs is regarded with high mortality and morbidity, particular for high level classification AVMs .

Blood oxygen level dependent fMRI can be used to mapping the motor and language regions of the brain noninvasively. It has been one of the most advanced functional imaging techniques and it has quickly grown to be a vital tool for clinical and cognitive neuroscience research. Many clinical researches have been reported about the utility of fMRI in brain tumor surgery. However, the effect of fMRI navigation for neurofunction protection in the intracranial arteriovenous malformation surgery was unclear.

We aim to perform a multicenter prospective randomized single -blind clinical trial to assess the safety and effect of fMRI navigation in the intracranial AVMs surgery. We hypothesize that application of blood oxygen level dependent fMRI is able to improve long term prognosis of patients.

Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery

Blood Oxygen Level Dependent fMRI Navigation for Function Protection in Intracranial Arteriovenous Malformation Surgery: a Multicenter Prospective Randomized Controlled Single Blind Clinical Trial

The scale runs from 0-6, running from perfect health without symptoms to death. 0-No symptoms.

1. No significant disability. Able to carry out all usual activities, despite some symptoms.
2. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. Moderate disability. Requires some help, but able to walk unassisted.
4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6. Dead.

Post operative epilepsy seizure, hemorrhage,infarction.

Beijing Tiantan Hospital

Symptoms and General Pathology

Thrombosis

Brain Neoplasms

Stroke

Aneurysm

Constriction, Pathologic

Carotid Stenosis

Sinus Thrombosis, Intracranial

Cavernous Sinus Thrombosis

Intracranial Aneurysm

Embolism

Embolism and Thrombosis

Carotid Artery Diseases

Arterial Occlusive Diseases

Intracranial Thrombosis

Intracranial Embolism

Intracranial Embolism and Thrombosis

Thromboembolism

Syndrome

Acute Graft Versus Host Disease

Anti-Infective Agents

All Drugs and Chemicals

Metronidazole

The procedure will be done using standard criteria as per operator preference. All interventional cases at our institution undergo a "radial first" approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr).

Patients who are undergoing endovascular intervention will be enrolled into the study. As the metrics analyzed in this study are already normally collected, this study can be considered as a secondary use of the data. The procedure will be done using standard criteria as per operator preference. All interventional cases at the study institution undergo a "radial first" approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr).

Transradial approach

Priyank Khandelwal, MD

The main objective of this single arm study is to evaluate the safety and feasibility of the AXS Infinity LS (Stryker, Freemont, CA, USA) and AXS Infinity LS Plus (Stryker, Freemont, CA, USA) catheters during the transradial approach through a secondary use of the data collected during neurointerventional procedures. This includes evaluating the conversion rates to a transfemoral approach. A secondary aim of the study is to assess the radial artery occlusion rates post procedure.

Patients who are undergoing endovascular intervention will be enrolled into the study. Consent will be obtained for the procedure and for the use of their prospectively collected clinical data. As the metrics analyzed in this study are already normally collected, this study can be considered as a secondary use of the data. The procedure will be done using standard criteria as per operator preference. All interventional cases at the study institution undergo a "radial first" approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr). If the artery does not meet the size criteria, only a 6Fr sheath will be used, and the data recorded during the procedure will not be utilized for analysis in this study. The preoperative and postoperative care will be the same for all the patients. No tests will be done outside of standard of care.

Safety and Feasibility of the Infinity Catheter for Radial Access

Safety and Feasibility of the Infinity Guide Catheter for Neuro Interventional Procedures Using Transradial Access

The size of the radial artery will be measured and the transradial approach will be used. Notation will be also be recorded if conversion to TFA is used.

Patient demographics will be analyzed such as past medical history, HTN, HLD, Afib

Rutgers, The State University of New Jersey

Assistant Professor

Cerebral arteriovenous malformation embolism

embolism

Jianmin Liu, Doctor

Chuanzhi Duan

Songtao Qi

Dong Zhou

Huaizhang Shi

Tianxiao Li

Jincao Chen

Ya Peng

Chunhua Hang

HanDong Wang

Xingen Zhu

Yuxiang Gu, Doctor

Jianmin Zhang

This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. in the process of clinical use to support the application of the National Medical Products Administration ( NMPA) product registration approval.

A prospective, multicenter, randomized controlled trial was used in this study. Onyx Liquid Embolic System and Marathon Flow Directed Micro Catheter, which were registered and marketed in China and had good effect in the industry, were selected as the control devices. Subjects requiring cerebral arteriovenous malformation embolization were selected to participate in the trial based on pathological conditions and inclusion/exclusion criteria, and the use of test products or control products was determined based on central randomized results. Imaging data involving the main evaluation criteria were evaluated uniformly by the blind evaluators of the leading unit, so as to reduce the bias caused by subjective factors of different evaluators.

Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

A Prospective, Multi-center, Randomized Parallel Controlled Study on the Safety and Effectiveness of the Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

Major adverse events related to instrumentation or surgical procedures within 1 month after surgery: bleeding during embolization, catheter indwelling, bleeding after embolization, symptomatic cerebral infarction, and edema.

Number of effective embolization subjects / Total number of subjects x 100%.Definition of effective embolization : Postoperative DSA angiographic malformation volume decreased ≥50%. Volume of malformed groups = length × width × height /2.

MRS refers to the modified Rankin scale, which is used to measure the neurological recovery of patients after stroke. It has a scale of zero to six. The higher the score, the worse the neurological function. MRS scores were collected at 1, 6 and 12 months after the operation before discharge .

Success is represented by the ability to reach the lesion and embolize the malformed mass of the intended target, followed by successful catheter withdrawal from the body

1. The ability of the catheter to reach the lesion .
2. The catheter has broken at the tip and perforated.
3. Intravascular complications associated with catheters occurred.
4. Degree of difficulty in tube withdrawal
5. Catheter jam

Suzhou Hengruihongyuan Medical Technology Co. LTD

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Musculoskeletal Diseases

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Coronary Artery Disease

Diabetes Mellitus

Diabetic Foot

Lung Diseases

Ear Diseases

Joint Diseases

Pneumonia

Coronary Disease

Myocardial Ischemia

Lung Diseases, Interstitial

Ulcer

Foot Ulcer

Kidney Calculi

Calculi

Nephrolithiasis

Hyperaldosteronism

Adrenocortical Adenoma

Labyrinth Diseases

Labyrinthitis

Adenoma

Ischemia

Heart Diseases

Arteriosclerosis

Respiratory Tract Diseases

Diabetic Angiopathies

Leg Ulcer

Skin Ulcer

Skin Diseases

Diabetes Complications

Endocrine System Diseases

Diabetic Neuropathies

Foot Diseases

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urolithiasis

Urinary Calculi

Male Urogenital Diseases

Pathological Conditions, Anatomical

Adrenocortical Hyperfunction

Adrenal Gland Diseases

Otorhinolaryngologic Diseases

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Otitis

Adenoma of the Adrenal Gland

Hyperadrenalism

Micronutrients

Zinc

Comparative intra-patients (each patient will have both types of scanner imaging done), clinical superiority study, evaluating the imaging performances (e.g. image quality and radiation dose) of SPCCT and standard DECT for several body regions/anatomical structures.

For the dual-layer spectral CT scanner (IQon®, Philips, Amsterdam, The Netherlands), the following parameters will be used for the acquisition:

* Tube potential 120 kVp;
* Tube current time product of 150 mAs;
* Gantry revolution time 0.33 s;
* Automatic exposure control (angular and longitudinal) combined xyz-axis;
* Beam collimation geometry 64 x 0.625 mm - scan field-of-view - 22 cm;

Spectral Photon Counting Computed Tomography (SPCCT)

The SPCCT scanner is a prototype spectral photon-counting computed tomography system derived from a modified clinical CT system with a field-of-view (FOV) of 168 mm in-plane, and a z-coverage of 20 mm. It is equipped with energy-sensitive photon-counting detectors relying on the direct conversion high band gap semiconductor of cadmium zinc telluride (CZT). The electronics comprises 5 rate counters with 5 different configurable energy thresholds. The SPCCT scanner has the following parameters:

* Base platform : iCT scanner
* Tube Voltage (kVp) : 120, capability for imaging at 80 and 100 kVp
* Tube current (mA) : 10 - 300
* Spatial Resolution : \> 30 lp/cm, ≤ 250 µm
* Z-coverage isocenter (mm) : 20 mm
* FOV (mm) : 500
* Minimum rotation time : 0.33 s/rotation
* Acquisition modes : Axial, Helical, Step \& Shoot

DECT (Dual Energy CT)

Philippe DOUEK, Pr

Adeline MANSUY

This pilot study wants to determine to which extent SPCCT allows obtaining images with improved quality and diagnostic confidence when compared to standard Dual Energy CT (DECT), both with and without contrast agent injection.

Depending on the anatomical structures/organs to be visualized during CT examinations, different scanning protocols are performed with quite variable ionizing radiation doses. Therefore, in order to obtain the most extensive and representative results of the improvement in image quality between SPCCT and DECT that will be performed CT imaging on several body regions and structures, including diabetic foot, diabetic calcium coronary scoring, adrenal glands, coronary arteries, lung parenchyma, kidney stones, inner ear, brain and joints, earl/temporal bone, colorectal carcinosis.

Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)

A single four-point scale will be used (1: unacceptable, 2: usable under limited conditions, 3: probably acceptable, 4: fully acceptable) based on the European guidelines on quality criteria for computed tomography

The diagnostic confidence grade will be calculated on a four-point scale (1: insufficient, 2: poor, 3: average, 4: good).

It will be calculated on a five-point scale (1: poor, 2: fair, 3: average, 4: good, 5: excellent) for each following criterion: noise, artifacts and sharpness.

To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.

The CTDI is an estimation of the dose delivered to the organs for each acquired section that is based on acquisition parameters of a water phantom with a 32 cm diameter. The value is expressed in milligray (mGy).

To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.

The DLP is obtained as follows: CTDI \* length of body explored = value in mGy.cm.

To determine the radiation dose delivered to the patients during the DECT and SPCCT imaging procedures.

The equivalent dose is obtained by multiplying the DLP to the specific organ conversion factor.

The noise by selecting regions of interest (ROI) will calculated.

The density (HU) by selecting regions of interest (ROI) will calculated.

The contrast-to-noise ratio (CNR) by selecting regions of interest (ROI) will calculated.

Depiction of anatomical structures of interest will be graded on a four-point scale (1: visualization just possible, 2: unclear borders but different structures already visible, 3: very good visualization, well-defined anatomy, 4: perfect delineation of anatomy).

An average radiation dose delivered to the patients for each clinical application will be calculated.

Statistical comparison between SPCCT and DECT will be performed over all images and anatomical structures globally and also for each clinical application of interest.

Hospices Civils de Lyon

Surgical resection of intracranial arteriovenous malformations.

Deliver a relatively high dose of focused radiation precisely to the arteriovenous malformations.

Deliver embolic materials to the feeding arteries or the nidus by microcatheters

Use two or three methods ( Surgical treatment stereotaxic radiosurgery endovascular treatment ) to cure the intracranial arteriovenous malformations

Patients refused to any of the treatment above

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room	NCT03209804	Intracranial Ar...	hybrid operatin...	18 Years - 70 Years	Ministry of Science and Technology of the People´s Republic of China
Functional Magnetic Resonance Imagine(fMRI)Navigation in Intracranial Arteriovenous Malformation Surgery	NCT01758211	Intracranial Ar...	fMRI Navigation... conventional re...	12 Years - 60 Years	Beijing Tiantan Hospital
Safety and Feasibility of the Infinity Catheter for Radial Access	NCT04553549	Brain Tumor Stroke, Acute Brain Aneurysm Intracranial Ar... Carotid Stenosi... Cavernous Sinus...	Transradial app...	18 Years -	Rutgers, The State University of New Jersey
Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations	NCT05058482	Intracranial Ar...	embolism	18 Years - 70 Years	Suzhou Hengruihongyuan Medical Technology Co. LTD
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room	NCT03209804	Intracranial Ar...	hybrid operatin...	18 Years - 70 Years	Ministry of Science and Technology of the People´s Republic of China
Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)	NCT04328181	Diabetic Foot U... Coronary Artery... Parenchymatous;... Kidney Stone Inner Ear Disea... Brain Stroke Joint Diseases Diabetes Adrenal Inciden... Hyperaldosteron... Macroadenoma Interstitial Lu... Intracranial Ar...	Spectral Photon... DECT (Dual Ener...	18 Years -	Hospices Civils de Lyon
Surgical Management of Cerebral Arteriovenous Malformations Within Hybrid Operation Room	NCT03209804	Intracranial Ar...	hybrid operatin...	18 Years - 70 Years	Ministry of Science and Technology of the People´s Republic of China
Nationwide Treatment Survey of Intracranial Arteriovenous Malformation in China	NCT01803685	Intracranial Ar...		-	Beijing Tiantan Hospital
Safety and Feasibility of the Infinity Catheter for Radial Access	NCT04553549	Brain Tumor Stroke, Acute Brain Aneurysm Intracranial Ar... Carotid Stenosi... Cavernous Sinus...	Transradial app...	18 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for intracranial arteriovenous malformations