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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transradial Approach | Experimental | 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. |
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| Transfemoral Approach | Active Comparator | Following successful femoral artery puncture, a 5F femoral sheath was inserted. After sheath placement, a heparinized saline flush was administered intra-arterially. Standard full cerebral angiography was then performed. Upon completion of the procedure, hemostasis was initially achieved via manual compression for 15-20 minutes, followed by the application of a pressure dressing which was maintained for 6-24 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral Angiography via the Transfemoral Approach | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 to 7 days |
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Inclusion Criteria:
5.Modified Rankin Scale (mRS) score ≤ 2 points; 6.Signed informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yin Rong | Contact | +8613919930466 | yin_rong_@163.com |
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| Cerebral Angiography via the Transradial Approach | Procedure | 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. |
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| 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. | 1 to 7 days |
| 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). | 1 to 24 hours |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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