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Completed

NCT Number: NCT07162064

Heparin for RAO Post-Transradial Angiography in AIS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tongji Hospital

Wuhan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Current anticoagulation therapy prior to procedure
  • Positive modified Allen's test result
  • History of coronary artery bypass grafting(CABG) with missing right radial artery graft
  • Severe forearm deformities (skin/musculoskeletal) or failed radial artery sheath placement
  • Suspected/confirmed pregnancy or lactation
  • Acute ischemic stroke with hemorrhagic transformation
  • Active systemic bleeding
  • Renal insufficiency (eGFR <30 mL/min or serum creatinine >200 μmol/L)
  • Investigator-determined ineligibility for trial participation

Treatment and study plan

Heparin - Therapeutic dosage

Drug

Intra-arterial sheath injection of heparin 2500 units before operation

Saline (0.9% NaCl)

Drug

Intra-arterial sheath injection of 2mL saline (0.9% sodium chloride)

Primary outcomes

  1. 24 hours radial artery occlusion rate after operation

    Time frame: 24 hours±12hours

    Radial artery occlusion rate was assessed by ultrasonography 24 hours±12hours after the procedure.

Sponsors and collaborators

Lead sponsor

Xiang Luo

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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