Status:
RECRUITING
Transradial Versus Transfemoral Access for Cerebral Angiography
Lead Sponsor:
Huashan Hospital
Conditions:
Cerebral Angiography
Eligibility:
All Genders
18-80 years
Phase:
NA
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 (TF...
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 incre...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years old;
- Scheduled to undergo diagnostic cerebral angiography;
- Suitable for cerebral angiography via TRA and TFA access, with a radial artery diameter ≥2mm confirmed by ultrasonography;
- Modified Rankin Scale (mRS) score ≤2;
- Provided written informed consent.
Exclusion
- Severe stenosis of the radial, brachial, subclavian, brachiocephalic, iliac or common femoral arteries, or any significant vascular disease (such as aortic aneurysm, etc.) that may obstruct guidewire passage;
- Arteriovenous fistula for hemodialysis present in the right upper limb;
- Planned interventional surgery within 24 hours of the initial study angiography;
- Requirement for cerebral angiography in an emergency department;
- Use of general anesthesia;
- Any contraindication to cerebral angiography, such as allergy or intolerance to the contrast media, uncorrected severe coagulation disorders, arterial dissection in the target vessel, puncture site infection, or renal insufficiency (Creatinine \[Gr\] \> 3 times of the upper limit of normal \[ULN\]), etc.;
- Women who are pregnant or planning to become pregnant within 1 year;
- Participation in another clinical trial;
- Any other condition deemed unsuitable for participation by the investigator.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2024
Estimated Enrollment :
748 Patients enrolled
Trial Details
Trial ID
NCT05401669
Start Date
September 15 2023
End Date
November 20 2024
Last Update
September 4 2024
Active Locations (1)
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1
Huashan Hospital
Shanghai, Shangai, China, 200000