Clinical trial NCT05401669: Transradial Versus Transfemoral Access for Cerebral Angiography
Official title: Transradial Versus Transfemoral Access for Cerebral Angiography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Angiography
Keywords: Cerebral Angiography
Transfemoral Arterial access
Transradial Arterial access
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 80 years old;
2. Scheduled to undergo diagnostic cerebral angiography;
3. Suitable for cerebral angiography via TRA and TFA access, with a radial artery diameter ≥2mm confirmed by ultrasonography;
4. Modified Rankin Scale (mRS) score ≤2;
5. Provided written informed consent.

Exclusion Criteria:

1. 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;
2. Arteriovenous fistula for hemodialysis present in the right upper limb;
3. Planned interventional surgery within 24 hours of the initial study angiography;
4. Requirement for cerebral angiography in an emergency department;
5. Use of general anesthesia;
6. 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.;
7. Women who are pregnant or planning to become pregnant within 1 year;
8. Participation in another clinical trial;
9. Any other condition deemed unsuitable for participation by the investigator.

Primary outcomes:
measure: the rate of successful diagnostic cerebral angiography
timeFrame: 24 hours
Secondary outcomes:
measure: the rate of successful accurate diagnosis
timeFrame: 24 hours
measure: the duration of angiography
timeFrame: During procedure
measure: the duration of fluoroscopy
timeFrame: During procedure
measure: the bedridden time
timeFrame: 24 hours
measure: the Visual Analogue Scale (VAS) score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shangai
Study officials:
affiliation: department of Neurosurgery, Huashan Hospital,Fudan University
name: Yuxiang Gu, PhD,MD
role: STUDY_CHAIR
affiliation: department of Neurosurgery, Huashan Hospital,Fudan University
name: Wei Ni, PhD,MD
role: STUDY_DIRECTOR
References: