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IRCT20241223064139N1 IRCT 2025-02-06 Mashhad University of Medical Sciences Evaluation of Cerebral Angiography via Transradial Cerebral Angiography (TRA) and Transfemoral Cerebral Angiography (TFA) Evaluation of the Safety and Efficacy of Cerebral Angiography via Transradial Cerebral Angiography (TRA) and Transfemoral Cerebral Angiography (TFA): A Randomized Clinical Trial 2023-04-18 anticipated 60 Complete https://irct.ir/trial/80975 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization was employed as a reliable method to ensure balanced allocation of participants across treatment groups at the end of each block. To generate variable-sized random blocks, the online tool available at https://www.sealedenvelope.com/simple-randomiser/v1/lists was used. The tool's output provided a specific number of blocks with varying sizes (4 and 6) and different sequences of block contents, based on the sample size and the suggested block sizes. Subsequently, the contents of each block were concealed in sealed envelopes (allocation concealment), and upon patient enrollment, one of the blocks was randomly selected. The participant was then assigned to a study arm according to the sequence specified within the block. Following the completion of the first block, the next block was randomly selected, and this process continued until the final block was exhausted and the last participant was allocated. Consequently, with the assignment of the final entry in the last block, participants were evenly distributed between the two study arms. To maintain impartiality, this procedure was carried out by an individual independent of the treatment team, Blinding description: This study employed single-blind masking, meaning that the patient remained unaware of the procedure type (transradial or transfemoral) to minimize subjective bias in outcome perception. To achieve this, the preparation, local anesthesia, and angiography procedures were conducted under appropriate coverage, ensuring that the patient does not receive any information regarding the access route. However, the treatment team (physicians and nurses) was aware of the procedure type, as this knowledge was essential for proper protocol implementation. To enhance accuracy, data analysis was performed by an individual or team blinded to group allocation (blinding in analysis or double-dummy). This approach minimized bias in result interpretation. N/A Common Cerebrovascular Diseases including Aneurysm, Arterial Stenosis or Occlusion, Vasculitis, Spasm, and Vascular Malformations or Fistula (Arteriovenous Malformation or Arteriovenous fistula). Intervention 1: Intervention1: Transradial Group:In This Group, Patients Undergo Cerebral Angiography Using The Transradial Approach (Access Via The Radial Artery In The Wrist). In This Method, A Catheter Is Inserted Through The Radial Artery And Guided Toward The Cerebral Arteries. Intervention 2: Intervention 2: Transfemoral Group:In This Group, Patients Undergo Cerebral Angiography Using The Transfemoral Approach (Access Via The Femoral Artery In The Groin Region). In This Method, A Catheter Is Inserted Through The Femoral Artery And Guided Toward The Cerebral Arteries. Yes - There is a plan to make this available What will be shared: In this study, the safety and efficacy of cerebral angiography using transradial and transfemoral access were compared and evaluated in patients. The collected data include demographic characteristics, clinical outcomes, access success rate, and potential adverse events. The documentation includes proposal forms, ethics approval, informed consent forms, raw data, statistical analysis tables (in SPSS format), and charts related to study results. Relevant information will be available upon request to qualified collaborators, subject to approval, via email (baharvahdath@mums.ac.ir). When: The data and documentation of this study will be available for public access for five years after the final results are published in a reputable scientific journal. To whom: Access to the data and documentation of this study will be available to researchers, university faculty, and others interested in scientific research related to the study topic. Requests for access must include a detailed explanation of the research purpose and approval from the relevant institution. Conditions: The data and documentation of this study may only be used for scientific research, statistical analyses, and knowledge advancement in the field of cerebral angiography. Use of these data is subject to compliance with research ethics guidelines, approval from the primary authors, and proper citation of the published article. Where to obtain: To request access to the data and documentation of this study, please contact the corresponding author, Dr. Humain Baharvahdat, via his official email (baharvahdath@mums.ac.ir). How to obtain: 1. The applicant must submit an official request to the corresponding author, including a detailed explanation of the research purpose, intended data usage, and approval from the relevant institution. 2. The request will be reviewed and approved if it aligns with scientific objectives and adheres to research ethics guidelines. 3. Upon approval, the applicant must sign a commitment to comply with data usage regulations and properly cite the published article. 4. Once the process is completed, the data and documentation will be provided to the applicant through a secure platform. Comments:
public Humain Baharvahdat
Qaem Hospital, Shariati Square, Ahmadabad Blv
Mashhad Iran (Islamic Republic of) Mashhad +98 51 3762 9341 baharvahdath@mums.ac.ir Mashhad University of Medical Sciences scientific Humain Baharvahdat
Qaem hospital, Shariati Square, Ahmadabad Blv
Mashhad Iran (Islamic Republic of) 991991766 +98 51 3762 9341 baharvahdath@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Individuals with Various Cerebral Disorders in Mashhad Who Underwent Cerebral Angiography Age more than 18 Years Old 18 years 80 years Both Cardiac Failure Renal Failure Patients with Non-Palpable Radial, Femoral, or Pedal Arteries Patients with Inaccessible Radial or Femoral Arteries or Anatomical Abnormalities that Prevent Angiography Patients with Hypersensitivity to Contrast Agents or Other Materials Used in the Angiography Procedure Pregnant or Breastfeeding Women for whom Angiography may pose Risks to the Fetus or Infant B31RZZZ Vascular syndromes of brain in cerebrovascular diseases Treatment - Surgery Treatment - Surgery Intervention1: Transradial Group:In This Group, Patients Undergo Cerebral Angiography Using The Transradial Approach (Access Via The Radial Artery In The Wrist). In This Method, A Catheter Is Inserted Through The Radial Artery And Guided Toward The Cerebral Arteries. Intervention 2: Transfemoral Group:In This Group, Patients Undergo Cerebral Angiography Using The Transfemoral Approach (Access Via The Femoral Artery In The Groin Region). In This Method, A Catheter Is Inserted Through The Femoral Artery And Guided Toward The Cerebral Arteries. The Prevalence of Sheath Placement Success in Angiography. Timepoint: After Intervention. Method of measurement: Fluoroscopy (Sheath Placement Success Rate). Radiation Dose. Timepoint: After Intervention. Method of measurement: Measurement Method: Using a fluoroscopy device that records the radiation dose absorbed by the patient. Unit: Milligray (mGy) or Entrance Skin Dose (ESD) in milligray and Dose-Area Product (DAP) in milligray per square centimeter (mGy·cm²). Surgery Time. Timepoint: After Intervention. Method of measurement: Time in Hour. Fluoroscopy Time. Timepoint: After Intervention. Method of measurement: Time in Hour. Degree of Disability/Dependence After The Stroke. Timepoint: After Intervention. Method of measurement: The Modified Rankin Scale (mRS). Patient Satisfaction. Timepoint: After Intervention. Method of measurement: Checklist Including Pain, Hematoma, Bruising, Edema, Discomfort, and Overall Satisfaction. Mashhad University of Medical Sciences Approved 2023-04-18 Ethics committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)