Transradial Versus Transfemoral Access for Cerebral Angiography

NCT05401669 | Recruiting DMC

• 1 other identifier: 2021Y9308
• Study Type: interventional
• Target: 748
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Angiography

Keywords

Cerebral Angiography; Transfemoral Arterial access; Transradial Arterial access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• the rate of successful accurate diagnosis

  24 hours

• the duration of angiography

  During procedure

• the duration of fluoroscopy

  During procedure

• the bedridden time

  24 hours

• the Visual Analogue Scale (VAS) score

  24 hours

Study Arms (2)

Trans-radial artery access

EXPERIMENTAL

Procedure: Trans-radial access

Trans-femoral Artery access

ACTIVE COMPARATOR

Procedure: Trans-femoral access

Interventions

Trans-radial access PROCEDURE

Cerebral angiography performed by trans-radial access

Trans-radial artery access

Trans-femoral access PROCEDURE

Cerebral angiography performed by trans-femoral access

Trans-femoral Artery access

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shangai, 200000, China

RECRUITING

Study Officials

• Yuxiang Gu, PhD,MD

  department of Neurosurgery, Huashan Hospital,Fudan University

  STUDY CHAIR

• Wei Ni, PhD,MD

  department of Neurosurgery, Huashan Hospital,Fudan University

  STUDY DIRECTOR

Central Study Contacts

Heng Yang, PhD, MD

CONTACT

13162909815; yangheng9011090@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-president of Huashan Hospital west campus

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 2, 2022
• Study Start: September 15, 2023
• Primary Completion: October 20, 2024
• Study Completion: November 20, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)