Transradial vs Transfemoral Group-Randomized Efficacy and Safety Trial for Cerebral Angiography

NCT07544043 | Not Yet Recruiting DMC

• 1 other identifier: 2026GSFYLS016
• Study Type: interventional
• Target: 2,473
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will compare the efficacy and safety of the transradial approach versus the transfemoral approach for performing full cerebral angiography. Participants will undergo cerebral angiography via one of the two approaches and will be followed up during and after the procedure. The primary endpoint of this study is to evaluate the success rate of completing full cerebral angiography (including superselective catheterization of bilateral common carotid arteries, subclavian arteries near the vertebral artery origin, and the aortic arch) via the transradial approach versus the transfemoral approach. During the study, the medical team will also document procedural details, incidence of complications, patient comfort, and related costs to comprehensively evaluate the clinical performance differences between the two approaches.

Conditions

Cerebrovascular Disease

Outcome Measures

Primary Outcomes (1)

• The completion of cerebral angiography

  The primary endpoint of this study is to evaluate the success rate of completing full cerebral angiography (including superselective catheterization of bilateral common carotid arteries, subclavian arteries near the vertebral artery origin, and the aortic arch) via the transradial approach versus the transfemoral approach

  30 minutes

Secondary Outcomes (3)

• The incidence of treatment-emergent adverse events (safety and tolerability) associated with TRA compared to TFA in cerebrovascular angiography

  1 to 7 days

• Comparative Cost-effectiveness of TRA versus TFA in Cerebrovascular Angiography

  1 to 7 days

• Visual Analogue Scale Score for Pain of TRA versus TFA in Cerebrovascular Angiography

  1 to 24 hours

Study Arms (2)

Transradial Approach

EXPERIMENTAL

Following successful radial artery puncture, a 5F radial sheath was inserted. After sheath placement, an intra-arterial cocktail was administered via the sheath, consisting of nitroglycerin 200 μg, verapamil 2.5 mg, and a heparinized saline flush (30-40 U/kg). Standard full cerebral angiography was then performed. Upon completion of the procedure, hemostasis was achieved using a dedicated radial artery compression device. The pressure was gradually released and completely removed 3-6 hours postoperatively.

Procedure: Cerebral Angiography via the Transradial Approach

Transfemoral Approach

ACTIVE COMPARATOR

Following successful femoral artery puncture, a 5F femoral sheath was inserted. After sheath placement, a heparinized saline flush was administered intra-arterially. Standard full cerebral angiography was then performed. Upon completion of the procedure, hemostasis was initially achieved via manual compression for 15-20 minutes, followed by the application of a pressure dressing which was maintained for 6-24 hours.

Procedure: Cerebral Angiography via the Transfemoral Approach

Interventions

Cerebral Angiography via the Transfemoral Approach PROCEDURE

Following successful radial artery puncture, a 5F radial sheath was inserted. After sheath placement, an intra-arterial cocktail was administered via the sheath, consisting of nitroglycerin 200 μg, verapamil 2.5 mg, and a heparinized saline flush (30-40 U/kg). Standard full cerebral angiography was then performed. Upon completion of the procedure, hemostasis was achieved using a dedicated radial artery compression device. The pressure was gradually released and completely removed 3-6 hours postoperatively.

Transfemoral Approach

Cerebral Angiography via the Transradial Approach PROCEDURE

Following successful radial artery puncture, a 5F radial sheath was inserted. After sheath placement, an intra-arterial cocktail was administered via the sheath, consisting of nitroglycerin 200 μg, verapamil 2.5 mg, and a heparinized saline flush (30-40 U/kg). Standard full cerebral angiography was then performed. Upon completion of the procedure, hemostasis was achieved using a dedicated radial artery compression device. The pressure was gradually released and completely removed 3-6 hours postoperatively.

Transradial Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• Patients requiring full cerebrovascular angiography;
• Objective evidence indicates the patient is suitable for transfemoral or transradial cerebrovascular angiography, with upper limb vascular ultrasound 4.showing a radial artery internal diameter ≥ 1.5 mm;
• Modified Rankin Scale (mRS) score ≤ 2 points; 6.Signed informed consent form.

You may not qualify if:

• Positive right Allen's test/Barbeau test; femoral artery occlusion (for the TFA group);
• Local infection or trauma at the puncture site;
• Coagulation abnormalities: INR \> 1.5 or platelet count \< 50 × 10⁹/L;
• Presence of access vessel disease or anatomical variation deemed potentially hazardous to the subject, such as aortic arch interruption, subclavian artery occlusion, or aortic dissection;
• Pregnancy;
• Planned or recent (within the past 2 weeks) major surgery or severe trauma;
• Expected survival less than 5 years;
• Severe cardiac, hepatic, renal, or other organ dysfunction;
• Contraindication to contrast agents used in cerebrovascular angiography;
• Inability to comply with follow-up.

Sponsors & Collaborators

• Gansu Provincial Maternal and Child Health Care Hospital: lead

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yin Rong

CONTACT

+8613919930466; yin_rong_@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04