Comparing two methods for accessing arteries during brain imaging

Transradial Versus Transfemoral Access for Cerebral Angiography

This study is testing whether a new way to access arteries in the wrist is safer and more effective than the traditional method from the groin for brain imaging procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 748 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shangai)
• Trial ID: NCT05401669 on ClinicalTrials.gov

What this trial studies

This multi-center, prospective, randomized controlled trial aims to evaluate the feasibility, safety, and success of Transradial access (TRA) compared to the traditional Transfemoral access (TFA) for diagnostic cerebral angiography. The study addresses the limitations and complications associated with TFA, such as pain and potential serious complications, by exploring the advantages of TRA, which has shown promise in coronary angiography. Participants will be randomly assigned to one of the two access methods to determine which is more effective for cerebral angiography procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who are scheduled for diagnostic cerebral angiography and meet specific vascular criteria.

Not a fit: Patients with significant vascular diseases or those requiring emergency cerebral angiography may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more comfortable procedures for patients undergoing cerebral angiography.

How similar studies have performed: While TRA has been successful in coronary angiography, this approach for cerebral angiography is novel and has not been extensively studied.

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.

Where this trial is running

Shanghai, Shangai

• Huashan Hospital — Shanghai, Shangai, China (Recruiting)

Study contacts

• Study coordinator: Heng Yang, PhD, MD

Conditions Cerebral Angiography; Transfemoral Arterial access; Transradial Arterial access