Evaluation of the Safety and Efficacy of Cerebral Angiography via Transradial Cerebral Angiography (TRA) and Transfemoral Cerebral Angiography (TFA): A Randomized Clinical Trial

Evaluation of the Safety and Efficacy of Cerebral Angiography via Transradial Cerebral Angiography (TRA) and Transfemoral Cerebral Angiography (TFA)

A Randomized, Single-Blind, Parallel-Group Clinical Trial with a Concealed Randomization Sequence, Including 245 Patients . Block Randomization was performed using the Sealed Envelope website, and Allocation Concealment was ensured through Sealed Envelopes.

Cerebral Angiography Patients in Qaem and Razavi Hospitals were Randomly assigned to Intervention or Control using Block Randomization with Sealed Envelopes Data, Baseline Info and Angiography Results, were Analyzed

Inclusion Criteria: Individuals with Various Cerebrovascular Diseases in Mashhad who have been Referred for Cerebral Angiography. Age above 18 Years. Exclusion Criteria: Heart 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.

Transradial Group: Patients underwent Cerebral Angiography using the Transradial Approach (via the Radial Artery). A Catheter was inserted through the Radial Artery and guided toward the Cerebral Arteries. Transfemoral Group: Patients underwent Cerebral Angiography using the Transfemoral Approach (via the Femoral Artery). A Catheter was inserted through the Femoral Artery and guided toward the Cerebral Arteries.

Primary Outcome Variables include Intraoperative and Postoperative Complications, Technical Success, and Patient Comfort in Both Angiography Methods.

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.

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.

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).

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.

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.

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.

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).

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.