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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Angiography
• Intervention / Treatment: Procedure: Trans-radial access; Procedure: Trans-femoral access

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 748
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heng Yang, PhD, MD; Phone Number: 13162909815; Email: yangheng9011090@163.com

Study Locations

• China
  • Shangai
    • Shanghai, Shangai, China, 200000
      • Recruiting
      • Huashan Hospital
      • Contact: Heng Yang, PhD,MD; Phone Number: 13162909815; Email: yangheng901109@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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;
2. Arteriovenous fistula for hemodialysis present in the right upper limb;
3. Planned interventional surgery within 24 hours of the initial study angiography;
4. Requirement for cerebral angiography in an emergency department;
5. Use of general anesthesia;
6. 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.;
7. Women who are pregnant or planning to become pregnant within 1 year;
8. Participation in another clinical trial;
9. Any other condition deemed unsuitable for participation by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trans-radial artery access	Procedure: Trans-radial access; Cerebral angiography performed by trans-radial access
Active Comparator: Trans-femoral Artery access	Procedure: Trans-femoral access; Cerebral angiography performed by trans-femoral access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of successful diagnostic cerebral angiography	the successful superselection of the aortic arch vessel without changing the arterial approach, with angiography results meeting diagnostic requirements	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of successful accurate diagnosis		24 hours
the duration of angiography	time taken to do the full procedure	During procedure
the duration of fluoroscopy	Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic cerebral angiography	During procedure
the bedridden time		24 hours
the Visual Analogue Scale (VAS) score		24 hours

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Study Chair: Yuxiang Gu, PhD,MD, department of Neurosurgery, Huashan Hospital,Fudan University; Study Director: Wei Ni, PhD,MD, department of Neurosurgery, Huashan Hospital,Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): November 20, 2024

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Angiography; Transfemoral Arterial access; Transradial Arterial access
• Other Study ID Numbers: 2021Y9308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No