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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06490848
Enrollment
600
Registered
2024-07-08
Start date
2020-01-01
Completion date
2024-12-01
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Angiography

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.

Interventions

PROCEDUREDiagnostic 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.

Sponsors

Mashhad University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
technical successduring procedureIncidence of sucess of performing the programmed cerebral angiogram through the randomised access without for crossover.
access successduring procedureIncidence of puncture success to insert a sheat in the access point

Secondary

MeasureTime frameDescription
total procedure timeduring procedurethe 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.
total fluoroscopy timeduring procedurethe duration of fluoroscopy
complicationduring procedure or one week after procedureincidence of any procedural-related complication procedure

Other

MeasureTime frameDescription
Patient Satisfactionimmediately after procedure, one hour after the procedureThe 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).

Countries

Iran

Contacts

Primary ContactHumain Baharvahdat, MD
humainbv@gmail.com+ 98 915 1100 400
Backup ContactFarid Qoorchi Moheb Seraj, MD
presfqm@gmail.com+98 936 939 24 44

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026