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RecruitingNCT06490848Updated Jul 8, 2024

Comparing the Safety and Efficacy of Cerebral TFA and TRA Methods

An interventional study of Diagnostic cerebral angiography in Cerebral Angiography, sponsored by Mashhad University of Medical Sciences. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-08.

Sponsored by Mashhad University of Medical Sciences · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Registered 3 years 9 months after the study started (first participant enrolled Jan 2020, registered Oct 2023).
  • Started Jan 2020; still recruiting 6 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cerebral Angiography
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In context

Lead sponsor

Mashhad University of Medical Sciences is the lead sponsor of 92 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    Transradial approach group

    The diagnostic angiography was performed by radial approach.

    Procedure: Diagnostic cerebral angiography

  • Active comparator
    Trasfemoral approach group

    The diagnostic angiography was performed by femoral approach.

    Procedure: 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.

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What researchers measure

Primary outcomes

  1. technical success

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

    Time frame: during procedure

  2. access success

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

    Time frame: during procedure

Secondary outcomes

  1. 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.

    Time frame: during procedure

  2. total fluoroscopy time

    the duration of fluoroscopy

    Time frame: during procedure

  3. complication

    incidence of any procedural-related complication procedure

    Time frame: during procedure or one week after procedure

Other outcomes

  1. 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).

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

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06490848
Lead sponsor
Mashhad University of Medical Sciences
Responsible party
Humain Baharvahdat (Associate Professor of Endovascular Neurosurgery, Mashhad University of Medical Sciences) — Principal investigator
First posted
Jul 8, 2024
Start date
Jan 1, 2020
Primary completion
Aug 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Jul 8, 2024

Study contacts

Humain Baharvahdat, MD
Contact
humainbv@gmail.com
+ 98 915 1100 400
Farid Qoorchi Moheb Seraj, MD
Contact
presfqm@gmail.com
+98 936 939 24 44

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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