Cerebrovascular DiseaseTARGET-CANCT07544043
Transradial vs Transfemoral Group-Randomized Efficacy and Safety Trial for Cerebral Angiography
A study testing Cerebral Angiography via the Transfemoral Approach and Cerebral Angiography via the Transradial Approach in people with Cerebrovascular Disease, run by Gansu Provincial Maternal and Child Health Care Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- Cerebral Angiography via the Transfemoral Approach and Cerebral Angiography via the Transradial Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,473 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 5.Modified Rankin Scale (mRS) score ≤ 2 points; 6.Signed informed consent form.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transradial vs Transfemoral Group-Randomized Efficacy and Safety Trial for Cerebral Angiography：A Prospective, Multicenter, Cluster-Randomized Controlled, Open-Label, Blinded Endpoint Evaluation Study（TARGET-CA）
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.
Read the detailed description
With the increasing global prevalence of cerebrovascular diseases and the growing demand for precise treatment, accurate diagnosis has become crucial. As the "gold standard" for diagnosing cerebrovascular diseases, digital subtraction angiography (DSA) is being increasingly utilized and required in clinical practice. For a long time, the transfemoral approach (TFA) has been the standard access route for clinical neurointervention due to its anatomical advantages, such as straight vascular pathways, strong instrument support, and ease of operation. However, as clinical cases accumulate, the limitations of TFA have become increasingly evident: the incidence of puncture site-related vascular complications (e.g., hematoma, pseudoaneurysm, retroperitoneal hemorrhage) is relatively high, and patients require strict bed rest and immobilization postoperatively. This not only leads to suboptimal perioperative comfort for patients but also significantly increases clinical nursing burdens and healthcare costs.
In the field of coronary intervention, multiple large-scale randomized controlled trials (e.g., the RIVAL study) have established the superiority of the transradial approach (TRA) in reducing bleeding complications and all-cause mortality. Inspired by this, TRA has gradually been applied in the field of neurointervention. The main advantages of TRA lie in the superficial location of the radial artery, which facilitates compression hemostasis, and the dual blood supply from the ulnar artery as collateral circulation, greatly reducing the risk of severe puncture site complications. Additionally, patients do not require bed rest postoperatively, significantly improving perioperative comfort and shortening perioperative time.
However, despite TRA becoming the first-line choice in cardiac intervention, its application in cerebrovascular angiography still faces unique challenges. Since cerebral vessels originate from the aortic arch, reaching the target vessels (especially the left carotid artery) from the radial artery involves navigating more tortuous anatomical pathways (such as the aortic arch and the turn of the innominate artery), which differs fundamentally from the anatomical pathways in coronary intervention. Therefore, conclusions from coronary intervention studies cannot be directly applied to the field of neurointervention. Currently, comparative studies of TRA and TFA in cerebrovascular angiography are mostly limited to single-center, retrospective analyses, and there remains a lack of high-quality prospective randomized controlled trials (RCTs) to provide high-level evidence-based medical data for evaluating their operational success rates, radiation exposure times, and long-term safety under different anatomical variations.
Based on this, this study aims to objectively evaluate the effectiveness and safety of the two approaches by comparing clinical data from TRA and TFA for full cerebrovascular angiography, thereby providing scientific evidence for clinical physicians to choose the optimal surgical pathway.
- Conditions
- Cerebrovascular Disease
- Being tested
- Cerebral Angiography via the Transfemoral Approach, Cerebral Angiography via the Transradial Approach
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral Angiography via the Transfemoral ApproachProcedure or surgery
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.
Cerebral Angiography via the Transradial ApproachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Cerebral Angiography via the Transfemoral Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (3)
The incidence of treatment-emergent adverse events (safety and tolerability) associated with TRA compared to TFA in cerebrovascular angiography
To evaluate the safety of TRA versus TFA in full cerebrovascular angiography by comparing complication rates (e.g., access-site hematoma, pseudoaneurysm, retroperitoneal hemorrhage), procedural duration, fluoroscopy time, and required bed rest duration
Measured: 1 to 7 days
Comparative Cost-effectiveness of TRA versus TFA in Cerebrovascular Angiography
To assess the cost-effectiveness of TRA versus TFA in full cerebrovascular angiography by analyzing direct and indirect costs associated with the procedure and the perioperative period.
Measured: 1 to 7 days
Visual Analogue Scale Score for Pain of TRA versus TFA in Cerebrovascular Angiography
To compare patient-reported pain levels between transradial access (TRA) and transfemoral access (TFA) in full cerebrovascular angiography. Pain will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 to 10, where higher scores indicate worse pain (i.e., a worse outcome).
Measured: 1 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,473 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gansu Provincial Maternal and Child Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544043
- Sponsor's protocol ID
- 2026GSFYLS016
- Acronym
- TARGET-CA
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transradial vs Transfemoral Group-Randomized Efficacy and Safety Trial for Cerebral Angiography：A Prospective, Multicenter, Cluster-Randomized Controlled, Open-Label, Blinded Endpoint Evaluation Study（TARGET-CA）
- ClinicalTrials.gov ID
- NCT07544043
- Acronym / sponsor ID
- TARGET-CA / 2026GSFYLS016
- Conditions
- Cerebrovascular Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,473 participants (estimated)
- Lead sponsor
- Gansu Provincial Maternal and Child Health Care HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
With the increasing global prevalence of cerebrovascular diseases and the growing demand for precise treatment, accurate diagnosis has become crucial. As the "gold standard" for diagnosing cerebrovascular diseases, digital subtraction angiography (DSA) is being increasingly utilized and required in clinical practice. For a long time, the transfemoral approach (TFA) has been the standard access route for clinical neurointervention due to its anatomical advantages, such as straight vascular pathways, strong instrument support, and ease of operation. However, as clinical cases accumulate, the limitations of TFA have become increasingly evident: the incidence of puncture site-related vascular complications (e.g., hematoma, pseudoaneurysm, retroperitoneal hemorrhage) is relatively high, and patients require strict bed rest and immobilization postoperatively. This not only leads to suboptimal perioperative comfort for patients but also significantly increases clinical nursing burdens and healthcare costs.
In the field of coronary intervention, multiple large-scale randomized controlled trials (e.g., the RIVAL study) have established the superiority of the transradial approach (TRA) in reducing bleeding complications and all-cause mortality. Inspired by this, TRA has gradually been applied in the field of neurointervention. The main advantages of TRA lie in the superficial location of the radial artery, which facilitates compression hemostasis, and the dual blood supply from the ulnar artery as collateral circulation, greatly reducing the risk of severe puncture site complications. Additionally, patients do not require bed rest postoperatively, significantly improving perioperative comfort and shortening perioperative time.
However, despite TRA becoming the first-line choice in cardiac intervention, its application in cerebrovascular angiography still faces unique challenges. Since cerebral vessels originate from the aortic arch, reaching the target vessels (especially the left carotid artery) from the radial artery involves navigating more tortuous anatomical pathways (such as the aortic arch and the turn of the innominate artery), which differs fundamentally from the anatomical pathways in coronary intervention. Therefore, conclusions from coronary intervention studies cannot be directly applied to the field of neurointervention. Currently, comparative studies of TRA and TFA in cerebrovascular angiography are mostly limited to single-center, retrospective analyses, and there remains a lack of high-quality prospective randomized controlled trials (RCTs) to provide high-level evidence-based medical data for evaluating their operational success rates, radiation exposure times, and long-term safety under different anatomical variations.
Based on this, this study aims to objectively evaluate the effectiveness and safety of the two approaches by comparing clinical data from TRA and TFA for full cerebrovascular angiography, thereby providing scientific evidence for clinical physicians to choose the optimal surgical pathway.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transradial Approach | Experimental | Procedure: Cerebral Angiography via the Transradial ApproachFollowing 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 | Active comparator | Procedure: Cerebral Angiography via the Transfemoral ApproachFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
- 5.Modified Rankin Scale (mRS) score ≤ 2 points; 6.Signed informed consent form.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral Angiography via the Transfemoral ApproachFollowing 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 or surgery | Transfemoral Approach |
| Cerebral Angiography via the Transradial ApproachFollowing 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 or surgery | Transradial Approach |
Primary outcome
The completion of cerebral angiography
Time frame: 30 minutes
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
3 secondary outcomes
The incidence of treatment-emergent adverse events (safety and tolerability) associated with TRA compared to TFA in cerebrovascular angiography
Time frame: 1 to 7 days
Comparative Cost-effectiveness of TRA versus TFA in Cerebrovascular Angiography
Time frame: 1 to 7 days
Visual Analogue Scale Score for Pain of TRA versus TFA in Cerebrovascular Angiography
Time frame: 1 to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral Angiography via the Transfemoral Approach and Cerebral Angiography via the Transradial Approach in people with Cerebrovascular Disease, run by Gansu Provincial Maternal and Child Health Care Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yin Rong (+8613919930466, yin_rong_@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The completion of cerebral angiography (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.