Transradial Versus Transfemoral Arterial Access for Cerebral Angiography

Not Applicable

Not yet recruiting

• Conditions: Cerebral Angiography
• Interventions: Procedure: Trans-radial access; Procedure: Trans-femoral access

• Registration Number: NCT05401669
• Lead Sponsor: Huashan Hospital

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.

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 Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-06-01
• Last Update Submitted: 2022-06-01
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02
• Study Start: 2022-10-20
• Primary Completion: 2024-10-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 748

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-radial artery access	Trans-radial access	-
Trans-femoral Artery access	Trans-femoral access	-

Primary Outcome Measures

Name	Time	Method
the rate of successful diagnostic cerebral angiography	24 hours	the successful superselection of the aortic arch vessel without changing the arterial approach, with angiography results meeting diagnostic requirements

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shangai, China