Carotid Artery Stenosis Without Infarction (Disorder)BEFITNCT06557135

Brachial Versus Femoral Access for Carotid Artery Stenting

A study testing Carotid Artery Stenting (CAS) in people with Carotid Artery Stenosis Without Infarction (Disorder) and Ischemic Stroke, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Study purpose: A multicenter, prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access. Eligible participants will be randomly assigned 1:1 to the brachial artery group or the femoral artery group. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carotid Artery Stenosis Without Infarction (Disorder), Ischemic Stroke
What is being tested?: Carotid Artery Stenting (CAS)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 235 participants
Where: 1 siteChina
Study dates: 27 Sep 2024to 31 Aug 2026
Phase: Interventional
Are there results?: None posted in the registry

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

Clinical diagnosis of stenosis at the origin of the carotid artery with indications for neuro-interventional treatment (symptomatic stenosis >50%; asymptomatic stenosis >70%)
Aged 18 or above
With palpable brachial and femoral arteries
The patient or his/her agent understands the purpose and needs of this study and signs the informed consent

Who cannot join

Symptomatic stenosis or occlusion of multiple vessels at the same time
Intravascular intervention for multiple vessel lesions at the same time
Ischemic stroke within the past 2 weeks
Any active bleeding, severe anaemia, or coagulation disorder. At least one of the following laboratory tests must be met: haemoglobin < 10g/dL, or platelet count < 100,000 /μ L, or unadjusted INR >1.5, or PT exceeds the upper limit of normal by 1 minute or heparin-induced thrombocytopenia
A large-area cerebral infarction stroke on the same side with sequelae may affect the judgment of the study endpoint
A history of cerebral hemorrhage in the past six months

Show all 12Show fewer

Any condition that may interfere with digital subtraction angiography (DSA) or cause unsafe percutaneous arterial access Participating in other clinical trials, in the research stage or follow-up stage
Contraindications to cerebral angiography, such as allergy to iodine contrast agents and renal insufficiency
Unable to understand or sign the informed consent form
Severe functional damage to important organs, assessed by clinical physicians to have high surgical risks and intolerant of interventional surgery
Baseline modified Rankin scale greater than or equal to 2
Expected survival is less than 6 months

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: Brachial vErsus Femoral Access for carotId Artery sTenting: a Multicenter Randomized Clinical Trial (BEFIT)

Study purpose:

A multicenter, prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access.

Eligible participants will be randomly assigned 1:1 to the brachial artery group or the femoral artery group.

Primary endpoint: surgical success rate.

Secondary endpoints:

Operation time (time from first arterial puncture to last angiography)
Serious adverse events (SAE) within 90 days;
Access puncture complications;

Read the detailed description

With the improvement of treatment concepts and the continuous innovation of interventional devices/interventional technologies, neurointervention has become the preferred treatment method for many cerebrovascular diseases. Among them, the femoral artery is the most commonly used access, because the femoral artery is superficial, easy to touch, and the relatively large vessel diameter allows most neurointerventional surgeries to proceed smoothly. However, the femoral artery access also has the disadvantages of long bed rest time, exposure to private parts, and prolonged hospitalization.

Thanks to the great success of radial artery access in cardiac intervention, radial artery access is increasingly being used in neurointervention. However, due to the thin radial artery, there is a significantly increased risk of complications (radial artery spasm, radial artery occlusion) during large-cavity nerve intervention, and the operation time is significantly prolonged. Therefore, the overall proportion of neurointerventional treatment via radial artery access in clinical practice is less than 12%.

As the superior vascular trunk of the radial artery, the brachial artery has a larger diameter and is theoretically more suitable to replace the radial artery for large-bore intervention. Anatomically, the brachial artery is superficial and easy to touch in the antecubital fossa, and there are no important vessels and nerves in front of the blood vessel, and the posterior is the distal humeral platform, which is easy for brachial artery puncture and postoperative compression hemostasis. Studies have shown that thrombectomy for cerebral artery occlusion and carotid artery stent placement can be safely performed through the brachial artery. However, current studies are based on single-center small sample studies, and there is still a lack of large-sample randomized controlled trials to verify the safety and effectiveness of neurointervention via the brachial artery.

This study intends to conduct a multicenter, prospective, and randomized study to compare the clinical results of carotid artery stent placement via the brachial and femoral artery access.

Conditions: Carotid Artery Stenosis Without Infarction (Disorder), Ischemic Stroke
Being tested: Carotid Artery Stenting (CAS)
Keywords: Brachial Artery, Femoral Artery, Carotid Artery Stenting, Carotid Stenosis
Medical subject headings: Ischemic Stroke, Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carotid Artery Stenting (CAS)Procedure or surgery
CAS involves inserting a catheter or tube into an artery in the brachial or the femoral, and then threading the catheter through the arteries of the body to the location of the stenosis within the carotid artery in the neck. A stent is then placed in the stenosis and holds the artery open.

Study groups in NCT06557135
Study group	Role	What they receive
the brachial group	Experimental	Patients with carotid artery stenosis will be randomly selected for carotid artery stenting via the brachial artery access. Receives: Procedure: Carotid Artery Stenting (CAS)
the femoral group	Active comparator	Patients with carotid artery stenosis will be randomly selected for carotid artery stenting via the femoral artery access. Receives: Procedure: Carotid Artery Stenting (CAS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Successful rate of CAS
Successful carotid artery stenting (CAS) is defined as access devices can be established, interventional devices can reach the lesion site, operations such as distal brain protection device release, balloon expansion and stent implantation, withdrawal protection device can be completed successfully, and residual stenosis < 30%.
Measured: 24 hours

Secondary outcomes (3)

Procedure time
time from first arterial puncture to last angiography
Measured: 24 hours
Serious adverse events (SAE)
SAEs related to operation and device are defined as those related to operation procedure and device determined by investigators. Includes the incidence of death, new-onset stroke, or severe haemorrhage events within 90 days post-procedure, et al.
Measured: 90 days
Access puncture complications
Hematoma at access puncture site, pseudoaneurysm, arteriovenous fistula, symptomatic severe stenosis/occlusion
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 202431 Aug 2026

First posted16 Aug 2024
Study start27 Sep 2024
Primary completion31 Aug 2026
Study completion31 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Carotid Artery Stenosis Without Infarction (Disorder)Studies of the same condition, open and under way.
More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 235 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06557135
Sponsor's protocol ID: 2024-SR-534
Acronym: BEFIT
Status last verified: Sep 2026
First submitted: 12 Aug 2024
Last updated: 25 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):4-90. doi: 10.1093/ejcts/ezy289. No abstract available.
PubMed 30165632
Kenawy AE, Tekle W, Hassan AE. Improved Fluoroscopy and Time Efficiency with Radial Access for Diagnostic Cerebral Angiography. J Neuroimaging. 2021 Jan;31(1):67-70. doi: 10.1111/jon.12807. Epub 2020 Nov 16.
PubMed 33191571
Stone JG, Zussman BM, Tonetti DA, Brown M, Desai SM, Gross BA, Jadhav A, Jovin TG, Jankowitz B. Transradial versus transfemoral approaches for diagnostic cerebral angiography: a prospective, single-center, non-inferiority comparative effectiveness study. J Neurointerv Surg. 2020 Oct;12(10):993-998. doi: 10.1136/neurintsurg-2019-015642. Epub 2020 Jan 22.
PubMed 31974282
Haussen DC, Nogueira RG, DeSousa KG, Pafford RN, Janjua N, Ramdas KN, Peterson EC, Elhammady MS, Yavagal DR. Transradial access in acute ischemic stroke intervention. J Neurointerv Surg. 2016 Mar;8(3):247-50. doi: 10.1136/neurintsurg-2014-011519. Epub 2015 Jan 5.
PubMed 25561585
Montorsi P, Galli S, Ravagnani MP, Teruzzi G, Calligaris G, Gili S, Caputi L, Troiano S, Del Maso R, Trabattoni D. Transradial/brachial carotid artery stenting with proximal protection: technical instructions, acute results and long-term outcomes. Minerva Cardiol Angiol. 2022 Dec;70(6):765-777. doi: 10.23736/S2724-5683.22.06223-8. Epub 2022 Dec 15.
PubMed 36519647
Lu CJ, Lin YH, Chu HJ, Tang SC, Lee CW. Safety and efficacy of the transbrachial approach for endovascular thrombectomy in patients with acute large vessel occlusion stroke. J Formos Med Assoc. 2021 Jan;120(1 Pt 3):705-712. doi: 10.1016/j.jfma.2020.08.002. Epub 2020 Aug 17.
PubMed 32819794
Starke RM, Snelling B, Al-Mufti F, Gandhi CD, Lee SK, Dabus G, Fraser JF; Society of NeuroInterventional Surgery. Transarterial and transvenous access for neurointerventional surgery: report of the SNIS Standards and Guidelines Committee. J Neurointerv Surg. 2020 Aug;12(8):733-741. doi: 10.1136/neurintsurg-2019-015573. Epub 2019 Dec 9.
PubMed 31818970
Naylor R, Rantner B, Ancetti S, de Borst GJ, De Carlo M, Halliday A, Kakkos SK, Markus HS, McCabe DJH, Sillesen H, van den Berg JC, Vega de Ceniga M, Venermo MA, Vermassen FEG, Esvs Guidelines Committee, Antoniou GA, Bastos Goncalves F, Bjorck M, Chakfe N, Coscas R, Dias NV, Dick F, Hinchliffe RJ, Kolh P, Koncar IB, Lindholt JS, Mees BME, Resch TA, Trimarchi S, Tulamo R, Twine CP, Wanhainen A, Document Reviewers, Bellmunt-Montoya S, Bulbulia R, Darling RC 3rd, Eckstein HH, Giannoukas A, Koelemay MJW, Lindstrom D, Schermerhorn M, Stone DH. Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease. Eur J Vasc Endovasc Surg. 2023 Jan;65(1):7-111. doi: 10.1016/j.ejvs.2022.04.011. Epub 2022 May 20. No abstract available.
PubMed 35598721
Kendrick DB, Strout TD. The minimum clinically significant difference in patient-assigned numeric scores for pain. Am J Emerg Med. 2005 Nov;23(7):828-32. doi: 10.1016/j.ajem.2005.07.009.
PubMed 16291435
Heck D, Jost A, Howard G. Stenting the carotid artery from radial access using a Simmons guide catheter. J Neurointerv Surg. 2022 Feb;14(2):169-173. doi: 10.1136/neurintsurg-2020-017143. Epub 2021 Feb 25.
PubMed 33632887
Jaroenngarmsamer T, Bhatia KD, Kortman H, Orru E, Krings T. Procedural success with radial access for carotid artery stenting: systematic review and meta-analysis. J Neurointerv Surg. 2020 Jan;12(1):87-93. doi: 10.1136/neurintsurg-2019-014994. Epub 2019 Jun 14.
PubMed 31201288
Dossani RH, Waqas M, Monteiro A, Cappuzzo JM, Almayman F, Snyder KV, Levy EI, Siddiqui AH, Davies JM. Use of a sheathless 8-French balloon guide catheter (Walrus) through the radial artery for mechanical thrombectomy: technique and case series. J Neurointerv Surg. 2022 May;14(5):neurintsurg-2021-017868. doi: 10.1136/neurintsurg-2021-017868. Epub 2021 Aug 24.
PubMed 34429347
Hernandez D, Requena M, Olive-Gadea M, de Dios M, Gramegna LL, Muchada M, Garcia-Tornel A, Diana F, Rizzo F, Rivera E, Rubiera M, Pinana C, Rodrigo-Gisbert M, Rodriguez-Luna D, Pagola J, Carmona T, Juega J, Rodriguez-Villatoro N, Molina C, Ribo M, Tomasello A. Radial Versus Femoral Access for Mechanical Thrombectomy in Patients With Stroke: A Noninferiority Randomized Clinical Trial. Stroke. 2024 Apr;55(4):840-848. doi: 10.1161/STROKEAHA.124.046360. Epub 2024 Feb 1.
PubMed 38299334

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brachial vErsus Femoral Access for carotId Artery sTenting: a Multicenter Randomized Clinical Trial (BEFIT)
ClinicalTrials.gov ID: NCT06557135
Acronym / sponsor ID: BEFIT / 2024-SR-534
Conditions: Carotid Artery Stenosis Without Infarction (Disorder), Ischemic Stroke
Keywords: Brachial Artery, Femoral Artery, Carotid Artery Stenting, Carotid Stenosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 235 participants (actual)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Study start: 27 Sep 2024 (actual)
Primary completion: 31 Aug 2026 (actual)
Study completion: 31 Aug 2026 (actual)
First posted: 16 Aug 2024 (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.

Study purpose:

A multicenter, prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access.

Eligible participants will be randomly assigned 1:1 to the brachial artery group or the femoral artery group.

Primary endpoint: surgical success rate.

Secondary endpoints:

Operation time (time from first arterial puncture to last angiography)
Serious adverse events (SAE) within 90 days;
Access puncture complications;

Detailed description

This study intends to conduct a multicenter, prospective, and randomized study to compare the clinical results of carotid artery stent placement via the brachial and femoral artery access.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
the brachial group	Experimental	Procedure: Carotid Artery Stenting (CAS)Patients with carotid artery stenosis will be randomly selected for carotid artery stenting via the brachial artery access.
the femoral group	Active comparator	Procedure: Carotid Artery Stenting (CAS)Patients with carotid artery stenosis will be randomly selected for carotid artery stenting via the femoral artery access.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Clinical diagnosis of stenosis at the origin of the carotid artery with indications for neuro-interventional treatment (symptomatic stenosis >50%; asymptomatic stenosis >70%)
Aged 18 or above
With palpable brachial and femoral arteries
The patient or his/her agent understands the purpose and needs of this study and signs the informed consent

Key exclusion criteria (12 listed)

Symptomatic stenosis or occlusion of multiple vessels at the same time
Intravascular intervention for multiple vessel lesions at the same time
Ischemic stroke within the past 2 weeks
Any active bleeding, severe anaemia, or coagulation disorder. At least one of the following laboratory tests must be met: haemoglobin < 10g/dL, or platelet count < 100,000 /μ L, or unadjusted INR >1.5, or PT exceeds the upper limit of normal by 1 minute or heparin-induced thrombocytopenia
A large-area cerebral infarction stroke on the same side with sequelae may affect the judgment of the study endpoint

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
Carotid Artery Stenting (CAS)CAS involves inserting a catheter or tube into an artery in the brachial or the femoral, and then threading the catheter through the arteries of the body to the location of the stenosis within the carotid artery in the neck. A stent is then placed in the stenosis and holds the artery open.	Procedure or surgery	the brachial group, the femoral group

Primary outcome

Successful rate of CAS
Time frame: 24 hours
Successful carotid artery stenting (CAS) is defined as access devices can be established, interventional devices can reach the lesion site, operations such as distal brain protection device release, balloon expansion and stent implantation, withdrawal protection device can be completed successfully, and residual stenosis < 30%.

3 secondary outcomes

Procedure time
Time frame: 24 hours
Serious adverse events (SAE)
Time frame: 90 days
Access puncture complications
Time frame: 90 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Background: PubMed 30165632Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):4-90. doi: 10.1093/ejcts/ezy289. No abstract available.
Background: PubMed 33191571Kenawy AE, Tekle W, Hassan AE. Improved Fluoroscopy and Time Efficiency with Radial Access for Diagnostic Cerebral Angiography. J Neuroimaging. 2021 Jan;31(1):67-70. doi: 10.1111/jon.12807. Epub 2020 Nov 16.
Background: PubMed 31974282Stone JG, Zussman BM, Tonetti DA, Brown M, Desai SM, Gross BA, Jadhav A, Jovin TG, Jankowitz B. Transradial versus transfemoral approaches for diagnostic cerebral angiography: a prospective, single-center, non-inferiority comparative effectiveness study. J Neurointerv Surg. 2020 Oct;12(10):993-998. doi: 10.1136/neurintsurg-2019-015642. Epub 2020 Jan 22.
Background: PubMed 25561585Haussen DC, Nogueira RG, DeSousa KG, Pafford RN, Janjua N, Ramdas KN, Peterson EC, Elhammady MS, Yavagal DR. Transradial access in acute ischemic stroke intervention. J Neurointerv Surg. 2016 Mar;8(3):247-50. doi: 10.1136/neurintsurg-2014-011519. Epub 2015 Jan 5.
Background: PubMed 36519647Montorsi P, Galli S, Ravagnani MP, Teruzzi G, Calligaris G, Gili S, Caputi L, Troiano S, Del Maso R, Trabattoni D. Transradial/brachial carotid artery stenting with proximal protection: technical instructions, acute results and long-term outcomes. Minerva Cardiol Angiol. 2022 Dec;70(6):765-777. doi: 10.23736/S2724-5683.22.06223-8. Epub 2022 Dec 15.
Background: PubMed 32819794Lu CJ, Lin YH, Chu HJ, Tang SC, Lee CW. Safety and efficacy of the transbrachial approach for endovascular thrombectomy in patients with acute large vessel occlusion stroke. J Formos Med Assoc. 2021 Jan;120(1 Pt 3):705-712. doi: 10.1016/j.jfma.2020.08.002. Epub 2020 Aug 17.
Background: PubMed 31818970Starke RM, Snelling B, Al-Mufti F, Gandhi CD, Lee SK, Dabus G, Fraser JF; Society of NeuroInterventional Surgery. Transarterial and transvenous access for neurointerventional surgery: report of the SNIS Standards and Guidelines Committee. J Neurointerv Surg. 2020 Aug;12(8):733-741. doi: 10.1136/neurintsurg-2019-015573. Epub 2019 Dec 9.
Background: PubMed 35598721Naylor R, Rantner B, Ancetti S, de Borst GJ, De Carlo M, Halliday A, Kakkos SK, Markus HS, McCabe DJH, Sillesen H, van den Berg JC, Vega de Ceniga M, Venermo MA, Vermassen FEG, Esvs Guidelines Committee, Antoniou GA, Bastos Goncalves F, Bjorck M, Chakfe N, Coscas R, Dias NV, Dick F, Hinchliffe RJ, Kolh P, Koncar IB, Lindholt JS, Mees BME, Resch TA, Trimarchi S, Tulamo R, Twine CP, Wanhainen A, Document Reviewers, Bellmunt-Montoya S, Bulbulia R, Darling RC 3rd, Eckstein HH, Giannoukas A, Koelemay MJW, Lindstrom D, Schermerhorn M, Stone DH. Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease. Eur J Vasc Endovasc Surg. 2023 Jan;65(1):7-111. doi: 10.1016/j.ejvs.2022.04.011. Epub 2022 May 20. No abstract available.
Background: PubMed 16291435Kendrick DB, Strout TD. The minimum clinically significant difference in patient-assigned numeric scores for pain. Am J Emerg Med. 2005 Nov;23(7):828-32. doi: 10.1016/j.ajem.2005.07.009.
Background: PubMed 33632887Heck D, Jost A, Howard G. Stenting the carotid artery from radial access using a Simmons guide catheter. J Neurointerv Surg. 2022 Feb;14(2):169-173. doi: 10.1136/neurintsurg-2020-017143. Epub 2021 Feb 25.
Background: PubMed 31201288Jaroenngarmsamer T, Bhatia KD, Kortman H, Orru E, Krings T. Procedural success with radial access for carotid artery stenting: systematic review and meta-analysis. J Neurointerv Surg. 2020 Jan;12(1):87-93. doi: 10.1136/neurintsurg-2019-014994. Epub 2019 Jun 14.
Background: PubMed 34429347Dossani RH, Waqas M, Monteiro A, Cappuzzo JM, Almayman F, Snyder KV, Levy EI, Siddiqui AH, Davies JM. Use of a sheathless 8-French balloon guide catheter (Walrus) through the radial artery for mechanical thrombectomy: technique and case series. J Neurointerv Surg. 2022 May;14(5):neurintsurg-2021-017868. doi: 10.1136/neurintsurg-2021-017868. Epub 2021 Aug 24.
Individual participant dataSharing planned: No

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. This study is not recruiting at the moment.

Sheng Liu, Professor principal investigator

The First Affiliated Hospital with Nanjing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 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: finished, as of the sponsor's last update on 25 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful rate of CAS (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06557135, which also lists 13 linked publications.

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 25 Sep 2026.