Transradial vs Transfemoral Group-Randomized Efficacy and Safety Trial for Cerebral Angiography

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGansu Provincial Maternal and Child Health Care Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cerebral Angiography via the Transfemoral Approach

    Procedure/Surgery

    Following 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/Surgery

    Following 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

2,473 Participants
are divided into 2 treatment groups
Group A: Transradial ApproachExperimental treatment 1 intervention
Group B: Transfemoral ApproachActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 minutes

Secondary outcomes

1

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

Time frame
1 to 7 days
2

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.

Time frame
1 to 7 days
3

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).

Time frame
1 to 24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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