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Clinical Trials/NCT05401669
NCT05401669
Not yet recruiting
Not Applicable

Transradial Versus Transfemoral Arterial Access for Cerebral Angiography

Huashan Hospital1 site in 1 country748 target enrollmentOctober 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Angiography
Sponsor
Huashan Hospital
Enrollment
748
Locations
1
Primary Endpoint
the rate of successful diagnostic cerebral angiography
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

This study is multi-center, prospective, randomized (1:1) controlled trial designed to assess and compare the feasibility, safety and success of Transradial access (TRA) versus Transfemoral access (TFA) for diagnostic cerebral angiography.

Detailed Description

TFA is traditional approach for diagnostic cerebral angiography, which has several limitations and complications including pain and discomfort, retroperitoneal hemorrhage, pulmonary embolism and increased admissions. Transradial coronary angiography has demonstrated preponderance to circumvent this limitations and complications. However, this has not been studied in cerebral angiography. So, the purpose of this study is to assess and compare the feasibility, safety and success of TRA versus TFA for diagnostic cerebral angiography.

Registry
clinicaltrials.gov
Start Date
October 20, 2022
End Date
December 20, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yuxiang Gu

Vice-president of Huashan Hospital west campus

Huashan Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 18-90 years
  • Planned cerebral angiography for clinical reason
  • Eligible for either transfemoral or transradial approach
  • Accept to sign the written consent form (WCF)

Exclusion Criteria

  • Contraindications to cerebral angiography, such as allergy to iodine contrast agents and renal insufficiency (GFR \< 30 ml/min), etc.;
  • Failure to complete the follow-up as required by the protocol;
  • Urgency/Emergency procedure
  • Patients are participating in other clinical trials;
  • Being pregnant or plan to get pregnant in the short term.

Outcomes

Primary Outcomes

the rate of successful diagnostic cerebral angiography

Time Frame: 24 hours

the successful superselection of the aortic arch vessel without changing the arterial approach, with angiography results meeting diagnostic requirements

Secondary Outcomes

  • the rate of successful accurate diagnosis(24 hours)
  • the duration of angiography(During procedure)
  • the duration of fluoroscopy(During procedure)
  • the bedridden time(24 hours)
  • the Visual Analogue Scale (VAS) score(24 hours)

Study Sites (1)

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