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NCT Number: NCT05401669

Transradial Versus Transfemoral Access for Cerebral Angiography

This study is multi-center, prospective, randomized (1:1) controlled trial designed to assess and compare the feasibility, safety and success of Transradial access (TRA) versus Transfemoral access (TFA) for diagnostic cerebral angiography.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital

Shanghai, Shangai, 200000, China

Location status: Recruiting

Location contact

Heng Yang, PhD,MD

CONTACT

[email protected]

13162909815

About this study

TFA is traditional approach for diagnostic cerebral angiography, which has several limitations and complications including pain and discomfort, retroperitoneal hemorrhage, pulmonary embolism and increased admissions. Transradial coronary angiography has demonstrated preponderance to circumvent this limitations and complications. However, this has not been studied in cerebral angiography. So, the purpose of this study is to assess and compare the feasibility, safety and success of TRA versus TFA for diagnostic cerebral angiography.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 80 years old;
  • Scheduled to undergo diagnostic cerebral angiography;
  • Suitable for cerebral angiography via TRA and TFA access, with a radial artery diameter ≥2mm confirmed by ultrasonography;
  • Modified Rankin Scale (mRS) score ≤2;
  • Provided written informed consent.

Exclusion criteria

  • Severe stenosis of the radial, brachial, subclavian, brachiocephalic, iliac or common femoral arteries, or any significant vascular disease (such as aortic aneurysm, etc.) that may obstruct guidewire passage;
  • Arteriovenous fistula for hemodialysis present in the right upper limb;
  • Planned interventional surgery within 24 hours of the initial study angiography;
  • Requirement for cerebral angiography in an emergency department;
  • Use of general anesthesia;
  • Any contraindication to cerebral angiography, such as allergy or intolerance to the contrast media, uncorrected severe coagulation disorders, arterial dissection in the target vessel, puncture site infection, or renal insufficiency (Creatinine [Gr] > 3 times of the upper limit of normal [ULN]), etc.;
  • Women who are pregnant or planning to become pregnant within 1 year;
  • Participation in another clinical trial;
  • Any other condition deemed unsuitable for participation by the investigator.

Treatment and study plan

Trans-radial access

Procedure

Cerebral angiography performed by trans-radial access

Trans-femoral access

Procedure

Cerebral angiography performed by trans-femoral access

Primary outcomes

  1. the rate of successful diagnostic cerebral angiography

    Time frame: 24 hours

    the successful superselection of the aortic arch vessel without changing the arterial approach, with angiography results meeting diagnostic requirements

Secondary outcomes

  1. the rate of successful accurate diagnosis

    Time frame: 24 hours

  2. the duration of angiography

    Time frame: During procedure

    time taken to do the full procedure

  3. the duration of fluoroscopy

    Time frame: During procedure

    Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic cerebral angiography

  4. the bedridden time

    Time frame: 24 hours

  5. the Visual Analogue Scale (VAS) score

    Time frame: 24 hours

Study contacts

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

Heng Yang, PhD, MD

CONTACT

[email protected]

13162909815

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2022
Registry last updated
Sep 4, 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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