Comparing the Safety and Efficacy of Cerebral TFA and TRA Methods

Not Applicable

Recruiting

• Conditions: Cerebral Angiography
• Interventions: Procedure: Diagnostic cerebral angiography

• Registration Number: NCT06490848
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2023-10-17
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trasfemoral approach group	Diagnostic cerebral angiography	The diagnostic angiography was performed by femoral approach.
Transradial approach group	Diagnostic cerebral angiography	The diagnostic angiography was performed by radial approach.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
total fluoroscopy time	during procedure	the duration of fluoroscopy
total procedure time	during procedure	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.
complication	during procedure or one week after procedure	incidence of any procedural-related complication procedure

Trial Locations

Locations (1)

Mashhad university of medical sciences; 🇮🇷 Mashhad, Razavi Khorasan, Iran, Islamic Republic of