Transradial Versus Transfemoral Access for Cerebral Angiography

NCT ID: NCT05401669

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 748 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-11-20

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.

Conditions

Cerebral Angiography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Trans-radial artery access

Group Type: EXPERIMENTAL

Trans-radial access

Intervention Type: PROCEDURE

Cerebral angiography performed by trans-radial access

Trans-femoral Artery access

Group Type: ACTIVE_COMPARATOR

Trans-femoral access

Intervention Type: PROCEDURE

Cerebral angiography performed by trans-femoral access

Interventions

Trans-radial access

Cerebral angiography performed by trans-radial access

Intervention Type: PROCEDURE

Trans-femoral access

Cerebral angiography performed by trans-femoral access

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuxiang Gu

Vice-president of Huashan Hospital west campus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuxiang Gu, PhD,MD

Role: STUDY_CHAIR

department of Neurosurgery, Huashan Hospital,Fudan University

Wei Ni, PhD,MD

Role: STUDY_DIRECTOR

department of Neurosurgery, Huashan Hospital,Fudan University

Locations

Huashan Hospital

Shanghai, Shangai, China

Site Status: RECRUITING

Countries

China

Central Contacts

Heng Yang, PhD, MD

Role: CONTACT

yangheng9011090@163.com

13162909815

Facility Contacts

Heng Yang, PhD,MD

Role: primary

yangheng901109@163.com

13162909815

Other Identifiers

2021Y9308

Identifier Type: -

Identifier Source: org_study_id