Transradial Versus Transfemoral Arterial Access for Cerebral Angiography

Cerebral Angiography Clinical Trial

Official title:

Transradial Versus Transfemoral Arterial Access for Cerebral Angiography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05401669
• Other study ID #: 2021Y9308
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: May 2022
• Source: Huashan Hospital
• Contact: Heng Yang, PhD, MD
• Phone: 13162909815
• Email: yangheng9011090[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 748
• Est. completion date: December 20, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Angiography

Intervention

Procedure:
• Trans-radial access
Cerebral angiography performed by trans-radial access
• Trans-femoral access
Cerebral angiography performed by trans-femoral access

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shangai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success	Finishing cerebral angiography without changing arterial access	24 hours
Secondary	Procedural related complications		24 hours
Secondary	Total procedure time	time taken to do the full procedure	During procedure
Secondary	Fluoroscopy time	Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic cerebral angiography	During procedure
Secondary	Amount of contrast used	Contrast volume (ml) used during the diagnostic cerebral angiography	During procedure
Secondary	Costs of cerebral angiography	Cerebral angiography and angiography related nursing expenses	30 days