Transradial Versus Transfemoral Arterial 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: Not yet 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 (Anticipated): 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
      • 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
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-90 years
2. Planned cerebral angiography for clinical reason
3. Eligible for either transfemoral or transradial approach
4. Accept to sign the written consent form (WCF)

Exclusion Criteria:

1. Contraindications to cerebral angiography, such as allergy to iodine contrast agents and renal insufficiency (GFR < 30 ml/min), etc.;
2. Failure to complete the follow-up as required by the protocol;
3. Urgency/Emergency procedure
4. Patients are participating in other clinical trials;
5. Being pregnant or plan to get pregnant in the short term.

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
Procedural success	Finishing cerebral angiography without changing arterial access	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural related complications		24 hours
Total procedure time	time taken to do the full procedure	During procedure
Fluoroscopy time	Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic cerebral angiography	During procedure
Amount of contrast used	Contrast volume (ml) used during the diagnostic cerebral angiography	During procedure
Costs of cerebral angiography	Cerebral angiography and angiography related nursing expenses	30 days

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 (Anticipated): October 20, 2022
• Primary Completion (Anticipated): October 20, 2024
• Study Completion (Anticipated): December 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): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: May 1, 2022

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