Transradial Carotid Artery StentingNCT07377422
Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via Transradial Access
A study testing Composite-Tip Transradial Neurovascular Distal Access Catheter and Straight or Single-Curve Tip Guiding Catheter in people with Transradial Carotid Artery Stenting and Novel Composite-tip Guiding Catheter, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This study aims to evaluate the safety and efficacy of the novel composite-tip guiding catheter for transradial access in Carotid Artery Stenting procedures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transradial Carotid Artery Stenting, Novel Composite-tip Guiding Catheter
- What is being tested?
- Composite-Tip Transradial Neurovascular Distal Access Catheter and Straight or Single-Curve Tip Guiding Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 16 Aug 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 who are candidates for endovascular intervention with CTA-confirmed stenosis in the common carotid artery or C1 segment of internal carotid artery(Symptomatic: ≥50% stenosis; Asymptomatic: 70%-99% stenosis）（NASCET criteria) ;
- Symptomatic carotid artery stenosis: Non-disabling ischemic stroke or transient ischemic symptoms (TIA, including hemispheric events or transient monocular blindness) within 180 days prior to randomization;
- Asymptomatic Carotid Stenosis: No history or examination findings suggestive of ipsilateral carotid ischemic symptoms(Non-carotid symptoms, contralateral carotid symptoms, symptom onset >180 days prior to randomization, or vertebrobasilar symptoms are classified as asymptomatic).
- Palpable radial pulse and negative Allen's test (confirming adequate ulnar collateral circulation);
- Feasible transradial access with achievable device delivery to the target lesion per operator assessment;
- Patients or legally authorized representatives comprehend the study purpose, voluntarily participate with signed informed consent, and commit to complete follow-up.
Who cannot join
- Patients with severe vascular tortuosity/dissection, extensive or diffuse atherosclerotic lesions involving the aortic arch or proximal common carotid artery, or post-surgical anatomy impeding catheter delivery;
- Severe stenosis, aneurysms ≥5mm in maximum diameter, arteriovenous malformations (AVM), or other significant cerebrovascular diseases in ipsilateral intracranial/extracranial arteries beyond the target vessel;
- Patients requiring simultaneous bilateral carotid interventions;
- Contraindicated in patients with severe allergies to interventional devices or agents related to carotid stenting (e.g., lidocaine, contrast agents, aspirin, clopidogrel);
- Preprocedural mRS ≥3;
- Progressive stroke within 2 weeks, hemorrhagic transformation of ischemic stroke within 3 months, or spontaneous intracranial hemorrhage within 12 months;
- Severe hematologic disorders (active bleeding, severe anemia, coagulopathy, or transfusion dependency), severe heart failure, severe hepatic/renal impairment, or acute coronary syndrome;
- Malignancy or life expectancy <1 year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital. Capital Medical University
Beijing, 100029
Xu Guo, +86-13810124068, guo_ball@hotmail.com
About this study
Official title: Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via Transradial Access: A Prospective, Multicenter, Randomized Controlled Trial
This study aims to evaluate the safety and efficacy of the novel composite-tip guiding catheter for transradial access in Carotid Artery Stenting procedures
- Being tested
- Composite-Tip Transradial Neurovascular Distal Access Catheter, Straight or Single-Curve Tip Guiding Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite-Tip Transradial Neurovascular Distal Access CatheterDevice
Carotid Artery Stenting via Transradial Access Using a Composite-Tip Neurovascular Distal Access Catheter
Straight or Single-Curve Tip Guiding CatheterDevice
Carotid Artery Stenting via Transradial Access Using Straight or Single-Curve Tip Guiding Catheter
| Study group | Role | What they receive |
|---|---|---|
| Composite-Tip Transradial Neurovascular Distal Access Catheter | Experimental | Not described Receives: Device: Composite-Tip Transradial Neurovascular Distal Access Catheter |
| Straight or Single-Curve Tip Guiding Catheter | Active comparator | Not described Receives: Device: Straight or Single-Curve Tip Guiding Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transradial Access Success Rate Within 10 Minutes
Measured: Intra-procedure
Secondary outcomes (14)
Success Rate of Transradial Access Carotid Artery Stenting
Measured: Immediately post-procedure
Primary Success Rate of Transradial Access Establishment
Measured: Intra-procedure
Transradial-to-Transfemoral Conversion Rate
Measured: Intra-procedure
X-ray Radiation Exposure
Measured: Intra-procedure
Clinician User Experience Assessment
Measured: Immediately post-procedure
National Institutes of Health Stroke Scale (NIHSS) Score
Measured: Pre-discharge
Post-Procedure Modified Rankin Scale (mRS) Score
Measured: Pre-discharge
Incidence Rate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of All-Cause Death
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Any Stroke
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Target Vessel-Related Ischemic Stroke
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Any Myocardial Infarction
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Any Revascularization
Measured: Pre-discharge，30 days post-procedure
Incidence Rate of Radial Artery Occlusion
Measured: Pre-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 May 2026
- Primary completion16 Jun 2027 (estimated)
- Study completion16 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transradial Carotid Artery StentingStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Xu, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377422
- Sponsor's protocol ID
- BC-CR202501
- Other IDs
- 2025AZC2008
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via Transradial Access: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07377422
- Acronym / sponsor ID
- BC-CR202501
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 16 Jun 2027 (estimated)
- Study completion
- 16 Aug 2027 (estimated)
- First posted
- 29 Jan 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 aims to evaluate the safety and efficacy of the novel composite-tip guiding catheter for transradial access in Carotid Artery Stenting procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Composite-Tip Transradial Neurovascular Distal Access Catheter | Experimental | Device: Composite-Tip Transradial Neurovascular Distal Access Catheter |
| Straight or Single-Curve Tip Guiding Catheter | Active comparator | Device: Straight or Single-Curve Tip Guiding Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years;
- Patients who are candidates for endovascular intervention with CTA-confirmed stenosis in the common carotid artery or C1 segment of internal carotid artery(Symptomatic: ≥50% stenosis; Asymptomatic: 70%-99% stenosis）（NASCET criteria) ;
- Palpable radial pulse and negative Allen's test (confirming adequate ulnar collateral circulation);
- Feasible transradial access with achievable device delivery to the target lesion per operator assessment;
- Patients or legally authorized representatives comprehend the study purpose, voluntarily participate with signed informed consent, and commit to complete follow-up.
Key exclusion criteria (8 listed)
- Patients with severe vascular tortuosity/dissection, extensive or diffuse atherosclerotic lesions involving the aortic arch or proximal common carotid artery, or post-surgical anatomy impeding catheter delivery;
- Severe stenosis, aneurysms ≥5mm in maximum diameter, arteriovenous malformations (AVM), or other significant cerebrovascular diseases in ipsilateral intracranial/extracranial arteries beyond the target vessel;
- Patients requiring simultaneous bilateral carotid interventions;
- Contraindicated in patients with severe allergies to interventional devices or agents related to carotid stenting (e.g., lidocaine, contrast agents, aspirin, clopidogrel);
- Preprocedural mRS ≥3;
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 |
|---|---|---|
| Composite-Tip Transradial Neurovascular Distal Access CatheterCarotid Artery Stenting via Transradial Access Using a Composite-Tip Neurovascular Distal Access Catheter | Device | Composite-Tip Transradial Neurovascular Distal Access Catheter |
| Straight or Single-Curve Tip Guiding CatheterCarotid Artery Stenting via Transradial Access Using Straight or Single-Curve Tip Guiding Catheter | Device | Straight or Single-Curve Tip Guiding Catheter |
Primary outcome
Transradial Access Success Rate Within 10 Minutes
Time frame: Intra-procedure
14 secondary outcomes
Success Rate of Transradial Access Carotid Artery Stenting
Time frame: Immediately post-procedure
Primary Success Rate of Transradial Access Establishment
Time frame: Intra-procedure
Transradial-to-Transfemoral Conversion Rate
Time frame: Intra-procedure
X-ray Radiation Exposure
Time frame: Intra-procedure
Clinician User Experience Assessment
Time frame: Immediately post-procedure
National Institutes of Health Stroke Scale (NIHSS) Score
Time frame: Pre-discharge
Post-Procedure Modified Rankin Scale (mRS) Score
Time frame: Pre-discharge
Incidence Rate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: Pre-discharge，30 days post-procedure
Incidence Rate of All-Cause Death
Time frame: Pre-discharge，30 days post-procedure
Incidence Rate of Any Stroke
Time frame: Pre-discharge，30 days post-procedure
Incidence Rate of Target Vessel-Related Ischemic Stroke
Time frame: Pre-discharge，30 days post-procedure
Incidence Rate of Any Myocardial Infarction
Time frame: Pre-discharge，30 days post-procedure
Incidence Rate of Any Revascularization
Time frame: Pre-discharge，30 days post-procedure
Incidence Rate of Radial Artery Occlusion
Time frame: Pre-discharge
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 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Composite-Tip Transradial Neurovascular Distal Access Catheter and Straight or Single-Curve Tip Guiding Catheter in people with Transradial Carotid Artery Stenting and Novel Composite-tip Guiding Catheter, run by Beijing Anzhen Hospital at 1 site in China.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xu Guo (+86-13810124068, guo_ball@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transradial Access Success Rate Within 10 Minutes (time frame: Intra-procedure). 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 5 Oct 2026.