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IRCT20140712018457N7 IRCT 2022-11-14 Tehran University of Medical Sciences Comparison of vascular complications in carotid artery stenting with and without the use of embolic protection device Evaluation of vascular complication incidence in patients with Internal Carotid Artery(ICA) stenosis treated with Carotid Artery Stenting (CAS) without Embolic protection device (EPD) in comparison to CAS with EPD 2022-10-07 anticipated 60 Complete https://irct.ir/trial/65801 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the restricted randomization method of the block randomization type. Blocking is usually used in order to balance the number of samples allocated to each of the study groups. This feature allows researchers to assign the same number of samples to each of the examined groups in circumstances where intermediate analyses are required during taking samples. The size of all the blocks is equal and will be 6 in this two-group experiment (including 3 participants in the intervention group and 3 participants in the control group). Additionally, random allocation software is used to generate random sequences using the block approach in addition to simple randomization. To conceal the random allocation, we utilize allocation concealment, which refers to the method of performing a random sequence on the research participants in such a way that the allocated group is unknown prior to the allocation of the individual. Using opaque letter envelopes sealed with a random sequence, each random sequence formed is recorded on a card, and the cards are placed inside the letter envelopes in the order they are inserted. To preserve a random sequence, the exterior surface of the envelopes is numbered in the same order. The letter envelope lids are then sealed with adhesive and set within a box. At the time of participant registration, one of the envelopes will be opened, revealing the individual's assigned group depending on the sequence in which the eligible participants entered the study, Blinding description: In this single-blinded study, the evaluation team who assess outcomes (Including the physician who examines the patients before and after the treatment to evaluate the intervention results and the radiologist who reviews MRI results) are blinded to the type of the treatment. In fact, the outcome evaluation team is not part of the treatment team and only evaluates the procedure outcome. N/A Carotid Stenosis. Intervention 1: Intervention group: Carotid artery stenting with an protective device in patient with carotid artery stenosis (A device used to reduce the risk of embolic complications during carotid artery stenting procedure. Type of device: EZ, Company Name: Boston Scientific). Intervention 2: Control group: Carotid artery stenting without a protective device in patient with carotid artery stenosis. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mahsa Alborzi
ADIR research center, Imam Khomeini Hospital, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1579 mahsaalborzi94@gmail.com Tehran University of Medical Sciences scientific Hossein Ghanaati
Medical Imaging center, Imam Khomeini Hospital, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1516 ghanaati@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years old Internal carotid artery stenosis more than 70% in asymptomatic patients Internal carotid artery stenosis more than 50% in symptomatic patients 18 years no limit Both Proper candidate for Endarterectomy Renal failure History of allergy to radio contrast agents. I65.2 Occlusion and stenosis of carotid artery Treatment - Devices Treatment - Devices Intervention group: Carotid artery stenting with an protective device in patient with carotid artery stenosis (A device used to reduce the risk of embolic complications during carotid artery stenting procedure. Type of device: EZ, Company Name: Boston Scientific) Control group: Carotid artery stenting without a protective device in patient with carotid artery stenosis. Brain stroke. Timepoint: Twenty-four hours after treatment (early complication), 6 months and 2 years after treatment. Method of measurement: Physical examination and history taking, Magnetic Resonance Imaging (MRI). Myocardial Infarction. Timepoint: Twenty-four hours after treatment (early complication), 6 months and 2 years after treatment. Method of measurement: Physical examination and history taking, Electrocardiography. New lesions in MR imaging (Diffusion-weighted imaging). Timepoint: Twenty-four hours after treatment. Method of measurement: MR Imaging. Carotid artery restenosis. Timepoint: 6 months and 2years after treatment. Method of measurement: Carotid artery ultrasonography. Mortality. Timepoint: Follow-up of patients 24 hours after treatment, 6 months and 2 years after treatment. Method of measurement: Physical examination and history taking, telephone follow-up. Tehran University of Medical Sciences Approved 2022-08-30 Imam Khomeini Hospital Complex Medical Ethics Committee Imam Khomeini Hospital Complex, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)