Comparing the Safety and Efficacy of Cerebral TFA and TRA Methods

Comparing the Safety and Efficacy of Cerebral Angiography Using Trans-femoral Approach Versus Trans-radial Approach

Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Angiography
• Intervention / Treatment: Procedure: Diagnostic cerebral angiography

Detailed Description

Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Humain Baharvahdat, MD; Phone Number: + 98 915 1100 400; Email: humainbv@gmail.com
• Study Contact Backup: Name: Farid Qoorchi Moheb Seraj, MD; Phone Number: +98 936 939 24 44; Email: presfqm@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Razavi Khorasan
    • Mashhad, Razavi Khorasan, Iran, Islamic Republic of
      • Recruiting
      • Mashhad University of Medical Sciences
      • Contact: Humain Baharvahdat, MD; Phone Number: +98 915 1100 400; Email: humainbv@gmail.com
      • Contact: Farid Qoorchi Moheb Seraj, MD; Phone Number: 98 936 939 24 44; Email: presfqm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All consecutive adult inpatients and outpatients referred for diagnostic cerebral angiography
• the presence of the right radial pulse and at least one femoral pulse

Exclusion Criteria:

• age<18
• pregnant patients
• occlusion of aorta or proximal both iliac/ femoral artery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transradial approach group; The diagnostic angiography was performed by radial approach.	Procedure: Diagnostic cerebral angiography; In transradial access, no preprocedural upper extremity collateral blood supply testing was completed. When the radial access is unsuccessful, it is shifted to ulnar or femoral access. All right arms were secured in the fully supine position to allow access to both radial and ulnar arteries. At the conclusion of radial access procedures, a TR band was applied to close the access. Neurological exams as well as radial artery pulse and pulse oximeter of the right first finger were assessed during and on discharge by trained recovery nurses. Femoral access was performed in a standard manner. After the access (femoral or radial), a cerebral angiogram was performed in a standard manner using appropriate catheters (vertebral, bern, Simmons 2 or 3) according to the access. For the radial access, the patient was slightly sedated.
Active Comparator: Trasfemoral approach group; The diagnostic angiography was performed by femoral approach.	Procedure: Diagnostic cerebral angiography; In transradial access, no preprocedural upper extremity collateral blood supply testing was completed. When the radial access is unsuccessful, it is shifted to ulnar or femoral access. All right arms were secured in the fully supine position to allow access to both radial and ulnar arteries. At the conclusion of radial access procedures, a TR band was applied to close the access. Neurological exams as well as radial artery pulse and pulse oximeter of the right first finger were assessed during and on discharge by trained recovery nurses. Femoral access was performed in a standard manner. After the access (femoral or radial), a cerebral angiogram was performed in a standard manner using appropriate catheters (vertebral, bern, Simmons 2 or 3) according to the access. For the radial access, the patient was slightly sedated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
technical success	Incidence of sucess of performing the programmed cerebral angiogram through the randomised access without for crossover.	during procedure
access success	Incidence of puncture success to insert a sheat in the access point	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total procedure time	the duration (minutes) between the insertion of sheath and removal of sheath. fluoroscopy time, the need for performing 3D angiography, dose area product (DAP), total radiation dose, successful puncture (successful insertion of radial artery sheath and femoral artery sheath). Procedures that yielded angiograms with acceptable quality through the subclavian artery injection (with an inflated blood pressure cuff on the arm), in cases of failed vertebral artery cannulation, were also considered successful.	during procedure
total fluoroscopy time	the duration of fluoroscopy	during procedure
complication	incidence of any procedural-related complication procedure	during procedure or one week after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	The pain evaluation by the Visual analog score (VAS) by trained nurses and recorded as the scoring system (No pain: 0; Mild:1-3; Moderate:4-7; Severe:8-10).	immediately after procedure, one hour after the procedure

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 4001116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes