Comparing the Safety and Efficacy of Cerebral TFA and TRA Methods

NCT06490848 | Recruiting

• 1 other identifier: 4001116
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Angiography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• total procedure time

  during procedure

• total fluoroscopy time

  during procedure

• complication

  during procedure or one week after procedure

Other Outcomes (1)

• Patient Satisfaction

  immediately after procedure, one hour after the procedure

Study Arms (2)

Transradial approach group

ACTIVE COMPARATOR

The diagnostic angiography was performed by radial approach.

Procedure: Diagnostic cerebral angiography

Trasfemoral approach group

ACTIVE COMPARATOR

The diagnostic angiography was performed by femoral approach.

Procedure: Diagnostic cerebral angiography

Interventions

Diagnostic cerebral angiography PROCEDURE

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.

Transradial approach group; Trasfemoral approach group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad university of medical sciences

Mashhad, Razavi Khorasan Province, Iran

RECRUITING

Central Study Contacts

Humain Baharvahdat, MD

CONTACT

+ 98 915 1100 400; humainbv@gmail.com

Farid Qoorchi Moheb Seraj, MD

CONTACT

+98 936 939 24 44; presfqm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endovascular Neurosurgery

Model Details: In this study, all consecutive patients referred for diagnostic cerebral angiography at a large academic tertiary care medical center were randomly assigned to two groups: right radial access versus femoral access for diagnostic cerebral angiography.

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: July 8, 2024
• Study Start: January 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

IR (1)