Effectiveness and Safety of Heparinization for Radial Artery Occlusion After Transradial Cerebral Angiography in Patients With Acute Ischemic Stroke - A Multicenter, Prospective, Double-blind, Randomized Trail

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Cerebral angiography is a critical diagnostic tool in neurology, serving as the gold standard for evaluating cerebrovascular stenosis, hemodynamics, aneurysms, and arteriovenous malformations. Compared to the traditional transfemoral approach, transradial cerebral angiography (TRA) offers advantages such as preserved patient privacy, immediate post-procedure mobility, shorter hospitalization, and fewer access-site complications. Consequently, TRA has gained increasing acceptance among patients and clinicians as the preferred vascular access . However, radial artery occlusion (RAO) remains a common complication post-TRA, with reported incidence rates varying widely (1%-33%). RAO is particularly concerning as the radial artery serves as a key access for both cardiac and neurovascular interventions; its occlusion limits future procedural options.Evidence from interventional cardiology suggests that intra-arterial heparin administration significantly reduces RAO risk.However, patients undergoing transradial cerebral angiography are predominantly those with cerebrovascular diseases, including acute ischemic stroke (AIS)-a population at potential risk for hemorrhagic transformation.Although the 2022 Chinese Expert Consensus on Neurointerventional Diagnosis and Treatment via Transradial Access recommends intra-sheath heparin injection to prevent RAO, this recommendation is largely extrapolated from coronary intervention data. While several studies indicate that low-dose heparin is safe in moderate-to-severe AIS patients without increasing intracranial hemorrhage risk , high-level evidence specific to neurointerventional procedures-particularly in AIS patients-remains lacking.This multicenter, double-blind, randomized controlled trial (RCT) aims to: Evaluate the efficacy of intra-arterial heparin in preventing RAO following TRA cerebral angiography.Assess the safety of heparin in AIS patients, with a focus on hemorrhagic complications. By addressing these questions, the study will provide evidence-based guidance to optimize TRA outcomes, balancing RAO prevention with bleeding risk in neurovascular interventions. Its findings hold significant clinical value for improving the safety and efficacy of transradial cerebral angiography.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Acute ischemic stroke onset within 7 days (inclusive)

• Patients undergoing cerebral angiography via transradial approach

• Participant or legal representative capable of providing informed consent

Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Luo
flydottjh@163.com
+862783663337
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 440
Treatments
Experimental: Heparin Group
Inject 2,500 units (2mL) of unfractionated heparin intra-arterially via sheath prior to angiography
Placebo_comparator: Saline (0.9% NaCl)
Inject 2ml saline intra-arterially via sheath prior to angiography
Related Therapeutic Areas
Sponsors
Leads: Xiang Luo

This content was sourced from clinicaltrials.gov