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

Official title

Transradial vs Transfemoral Group-Randomized Efficacy and Safety Trial for Cerebral Angiography：A Prospective, Multicenter, Cluster-Randomized Controlled, Open-Label, Blinded Endpoint Evaluation Study（TARGET-CA）

Overview

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.

Detailed description

With the increasing global prevalence of cerebrovascular diseases and the growing demand for precise treatment, accurate diagnosis has become crucial. As the "gold standard" for diagnosing cerebrovascular diseases, digital subtraction angiography (DSA) is being increasingly utilized and required in clinical practice. For a long time, the transfemoral approach (TFA) has been the standard access route for clinical neurointervention due to its anatomical advantages, such as straight vascular pathways, strong instrument support, and ease of operation. However, as clinical cases accumulate, the limitations of TFA have become increasingly evident: the incidence of puncture site-related vascular complications (e.g., hematoma, pseudoaneurysm, retroperitoneal hemorrhage) is relatively high, and patients require strict bed rest and immobilization postoperatively. This not only leads to suboptimal perioperative comfort for patients but also significantly increases clinical nursing burdens and healthcare costs.

In the field of coronary intervention, multiple large-scale randomized controlled trials (e.g., the RIVAL study) have established the superiority of the transradial approach (TRA) in reducing bleeding complications and all-cause mortality. Inspired by this, TRA has gradually been applied in the field of neurointervention. The main advantages of TRA lie in the superficial location of the radial artery, which facilitates compression hemostasis, and the dual blood supply from the ulnar artery as collateral circulation, greatly reducing the risk of severe puncture site complications. Additionally, patients do not require bed rest postoperatively, significantly improving perioperative comfort and shortening perioperative time.

However, despite TRA becoming the first-line choice in cardiac intervention, its application in cerebrovascular angiography still faces unique challenges. Since cerebral vessels originate from the aortic arch, reaching the target vessels (especially the left carotid artery) from the radial artery involves navigating more tortuous anatomical pathways (such as the aortic arch and the turn of the innominate artery), which differs fundamentally from the anatomical pathways in coronary intervention. Therefore, conclusions from coronary intervention studies cannot be directly applied to the field of neurointervention. Currently, comparative studies of TRA and TFA in cerebrovascular angiography are mostly limited to single-center, retrospective analyses, and there remains a lack of high-quality prospective randomized controlled trials (RCTs) to provide high-level evidence-based medical data for evaluating their operational success rates, radiation exposure times, and long-term safety under different anatomical variations.

Based on this, this study aims to objectively evaluate the effectiveness and safety of the two approaches by comparing clinical data from TRA and TFA for full cerebrovascular angiography, thereby providing scientific evidence for clinical physicians to choose the optimal surgical pathway.

Interventions

• Procedure Cerebral Angiography via the Transfemoral Approach
  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 posto
• Procedure Cerebral Angiography via the Transradial Approach
  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 posto

Primary outcome measures

• The completion of cerebral angiography [Time frame: 30 minutes]

Secondary outcome measures (3)

• The incidence of treatment-emergent adverse events (safety and tolerability) associated with TRA compared to TFA in cerebrovascular angiography [Time frame: 1 to 7 days]
• Comparative Cost-effectiveness of TRA versus TFA in Cerebrovascular Angiography [Time frame: 1 to 7 days]
• Visual Analogue Scale Score for Pain of TRA versus TFA in Cerebrovascular Angiography [Time frame: 1 to 24 hours]

Eligibility criteria

Inclusion criteria

• 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;

5.Modified Rankin Scale (mRS) score ≤ 2 points; 6.Signed informed consent form.

Exclusion criteria

• 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;
• Pregnancy;
• Planned or recent (within the past 2 weeks) major surgery or severe trauma;
• Expected survival less than 5 years;
• Severe cardiac, hepatic, renal, or other organ dysfunction;
• Contraindication to contrast agents used in cerebrovascular angiography;
• Inability to comply with follow-up.

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

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07544043 · 2026GSFYLS016

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗