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NCT Number: NCT06490848

Comparing the Safety and Efficacy of Cerebral TFA and TRA Methods

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.

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Key information

Conditions

Cerebral Angiography

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. technical success

    Time frame: during procedure

    Incidence of sucess of performing the programmed cerebral angiogram through the randomised access without for crossover.

  2. access success

    Time frame: during procedure

    Incidence of puncture success to insert a sheat in the access point

Secondary outcomes

  1. total procedure time

    Time frame: 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.

  2. total fluoroscopy time

    Time frame: during procedure

    the duration of fluoroscopy

  3. complication

    Time frame: during procedure or one week after procedure

    incidence of any procedural-related complication procedure

Other outcomes

  1. Patient Satisfaction

    Time frame: immediately after procedure, one hour after the procedure

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Farid Qoorchi Moheb Seraj, MD

CONTACT

[email protected]

+98 936 939 24 44

Humain Baharvahdat, MD

CONTACT

[email protected]

+ 98 915 1100 400

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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