Transradial Versus Transfemoral Access for Cerebral Angiography

Overview

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.

Interventions

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

Primary outcome measures

• the rate of successful diagnostic cerebral angiography [Time frame: 24 hours]

Secondary outcome measures (5)

• the rate of successful accurate diagnosis [Time frame: 24 hours]
• the duration of angiography [Time frame: During procedure]
• the duration of fluoroscopy [Time frame: During procedure]
• the bedridden time [Time frame: 24 hours]
• the Visual Analogue Scale (VAS) score [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

China · 1 center

• Huashan Hospital — Shanghai

Publications

• Ni W, Yang H, Su J, Peng Y, Wang D, Lin Z, Sun J, Chen X, Wang J, Li Y, Wang J, Wan S, Ye X, Zhang Q, Wang D, Gao C, Jiang H, Gao X, Zhang Y, Han B, Cao J, Zhu X, Zhou S, Zeng Y, Chen F, Lin Y, Ba H, Chen X, Liu X, Hao J, Sun Z, Li M, Wang M, Xie D, Zhuang Z, Shi L, Zhou L, Tang H, Chen D, Anderson CS, Kang D, Gu Y; TRACE Investigators. Transradial vs Transfemoral Access for Cerebral Angiography: PMID 41854613

Identifiers

NCT: NCT05401669 · 2021Y9308

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗