About this trial
This study will compare the efficacy and safety of the transradial approach versus the transfemoral approach for performing full cerebral angiography. Participants will undergo cerebral angiography via one of the two approaches and will be followed up during and after the procedure. The primary endpoint of this study is to evaluate the success rate of completing full cerebral angiography (including superselective catheterization of bilateral common carotid arteries, subclavian arteries near the vertebral artery origin, and the aortic arch) via the transradial approach versus the transfemoral approach. During the study, the medical team will also document procedural details, incidence of complications, patient comfort, and related costs to comprehensively evaluate the clinical performance differences between the two approaches.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years;
Patients requiring full cerebrovascular angiography;
Objective evidence indicates the patient is suitable for transfemoral or transradial cerebrovascular angiography, with upper limb vascular ultrasound 4.showing a radial artery internal diameter ≥ 1.5 mm;
Disqualifiers
Positive right Allen's test/Barbeau test; femoral artery occlusion (for the TFA group);
Local infection or trauma at the puncture site;
Coagulation abnormalities: INR > 1.5 or platelet count < 50 × 10⁹/L;
Presence of access vessel disease or anatomical variation deemed potentially hazardous to the subject, such as aortic arch interruption, subclavian artery occlusion, or aortic dissection;
Trial design
Parallel
Treatments tested in this trial
Cerebral Angiography via the Transfemoral Approach
Procedure/SurgeryFollowing successful radial artery puncture, a 5F radial sheath was inserted. After sheath placement, an intra-arterial cocktail was administered via the sheath, consisting of nitroglycerin 200 μg, verapamil 2.5 mg, and a heparinized saline flush (30-40 U/kg). Standard full cerebral angiography was then performed. Upon completion of the procedure, hemostasis was achieved using a dedicated radial artery compression device. The pressure was gradually released and completely removed 3-6 hours postoperatively.
Cerebral Angiography via the Transradial Approach
Procedure/SurgeryFollowing successful radial artery puncture, a 5F radial sheath was inserted. After sheath placement, an intra-arterial cocktail was administered via the sheath, consisting of nitroglycerin 200 μg, verapamil 2.5 mg, and a heparinized saline flush (30-40 U/kg). Standard full cerebral angiography was then performed. Upon completion of the procedure, hemostasis was achieved using a dedicated radial artery compression device. The pressure was gradually released and completely removed 3-6 hours postoperatively.
Treatment groups
Trial outcomes
Primary outcomes
The completion of cerebral angiography
The primary endpoint of this study is to evaluate the success rate of completing full cerebral angiography (including superselective catheterization of bilateral common carotid arteries, subclavian arteries near the vertebral artery origin, and the aortic arch) via the transradial approach versus the transfemoral approach
Secondary outcomes
The incidence of treatment-emergent adverse events (safety and tolerability) associated with TRA compared to TFA in cerebrovascular angiography
To evaluate the safety of TRA versus TFA in full cerebrovascular angiography by comparing complication rates (e.g., access-site hematoma, pseudoaneurysm, retroperitoneal hemorrhage), procedural duration, fluoroscopy time, and required bed rest duration
Comparative Cost-effectiveness of TRA versus TFA in Cerebrovascular Angiography
To assess the cost-effectiveness of TRA versus TFA in full cerebrovascular angiography by analyzing direct and indirect costs associated with the procedure and the perioperative period.
Visual Analogue Scale Score for Pain of TRA versus TFA in Cerebrovascular Angiography
To compare patient-reported pain levels between transradial access (TRA) and transfemoral access (TFA) in full cerebrovascular angiography. Pain will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 to 10, where higher scores indicate worse pain (i.e., a worse outcome).
Locations
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