Ischemic StrokeRACE-CASNCT05416853
Radial Versus Femoral Access For Carotid Artery Stenting
A study testing Carotid Artery Stenting (CAS) in people with Ischemic Stroke and Carotid Stenosis, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial summary
Background: For moderate to severe carotid artery atherosclerotic stenosis, in the past decades, carotid artery stenting (CAS) has been an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Carotid Stenosis, Cerebral Revascularization
- 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
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2022to 20 Mar 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
- General inclusion criteria
- 1) Age≥18 years old
- Clinical inclusion criteria
- Symptomatic stenosis: patients had a transient ischemic attack (TIA), amaurosis, or minor nondisabling stroke involving the target carotid artery within 180 days before randomization.
- Asymptomatic stenosis: The results of medical history, physical examination and neurological examination do not suggest ischemic symptoms in the target carotid artery. If artery stenosis degree reache the standard, but there are any one or more of the following symptoms including: non-carotid artery symptoms; contralateral carotid artery symptoms; time from symptom to randomization more than 180 days; and vertebrobasilar artery symptoms. In these situations, patients are considered to be asymptomatic.
- Pulsation is palpable in the radial and femoral arteries, and the radial artery must meet any of the following criteria: Allen test or Barbeau test suggesting that ulnar artery collateral circulation is good, or preoperative ultrasound confirming that the radial artery and ulnar artery are well developed.
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- No family planning within half one year after informed consent signed, or negative pregnancy test for women with childbearing potential.
- Patients or their guardians can understand the study purpose, voluntarily participate in the trial, sign informed consent, and complete follow-up visits.
- Vascular inclusion criteria
- Lesions located in the internal carotid artery, with or without involvement of the adjacent common carotid artery (CCA).
- For symptomatic patients, at least one of the following conditions should be met: stenosis of 70% or more on ultrasonography; 70% or more on computed tomographic angiography (CTA) or magnetic resonance angiography (MRA); 50% or more on digital subtraction angiography (DSA) according to NASCET standard.
- For asymptomatic patients, at least one of the following conditions should be met: stenosis of 70% or more on ultrasonography; 80% or more on CTA or MRA; 60% or more on DSA according to NASCET standard.
- When bilateral carotid stenosis presented, only unilateral carotid artery can be treated. The other carotid artery, as a non-study artery, should be dealt with 30 days before randomization or 30 days after treatment.
- According to clinician experience, the operation access would be reasonable and the surgical instruments could be successfully delivered to the lesion site.
Who cannot join
- General exclusion criteria
- Progressive stroke.
- Allergic to drugs associated with carotid artery stenting, such as lidocaine, aspirin, clopidogrel, etc.
- Allergic to contrast media or interventional device.
- Any active hemorrhage, severe anemia, coagulation disorders, or unnecessary blood transfusion treatment. Meet at least one of the following laboratory tests: hemoglobin < 10g/dL, or platelet count < 100000 /μ L, or unadjusted INR >1.5, or PT beyond upper limit of normal for 1 minute, or heparin-induced thrombocytopenia.
- Previous ipsilateral large cerebral infarction stroke with sequelae, which can affect the judgment of the study end point.
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- Severe cognitive disorder, unable to cooperate with treatment or postoperative evaluation.
- Spontaneous intracranial hemorrhage occurred 12 months prior to informed consent written. Ischemic stroke hemorrhage transformation occurred 3 months prior to informed consent signed.
- A new-onset stroke occurred 7 days prior to informed consent signed, which has a high hemorrhagic transformation risk after preoperative imaging evaluation.
- Any condition that could interfere with digital subtraction angiography (DSA) or make percutaneous arterial access unsafe.
- Neurological disorders occurred 2 years prior to informed consent signed, which has transient or fixed neurological deficits, cannot be distinguished from TIA or stroke.
- Participating in other clinical trials, in the research phase or follow-up phase.
- Unable to understand or sign the informed consent.
- Myocardial infarction within 30 days.
- High surgical risk, intolerance to interventional surgery, e.g., coronary artery stenosis ≥70% without or unable to revascularization; ejection fraction < 30% or NYHA classification ≥class III; stable angina pectoris (static angina pectoris with ECG changes); organ transplantation (such as heart, lung, liver and kidney) planned or under evaluation; malignant tumour or respiratory insufficiency making life expectancy less than 5 years or FEV1< 30%(prediction); dialysis-dependent renal failure; poorly controlled diabetes mellitus(fast serum glucose >400 mg/dl and urine ketone > +2).
- Diseases or anatomical features that would prevent from carotid artery stenting, such as pathway problems caused by cervical radiation therapy, and cervical space occupying lesion compressing carotid artery
- Vascular exclusion criteria
- Severe vascular tortuosity or dissection that influence catheters delivering
- Stenting, balloon dilation or coiling were performed in ipsilateral vessels in the past.
- Extensive or diffuse atherosclerotic disease involving the aortic arch and the proximal common carotid artery, which would influence catheters delivering
- Besides the target vessel, there are also ipsilateral intracranial or extracranial arteries stenosis larger than the target lesion, aneurysms with the longest diameter ≥5 mm, cerebrovascular AVM(arteriovenous malformation), or other cerebrovascular disease with abnormal cerebral angiography.
- Ipsilateral carotid artery chronic occlusions.
- Plan to perform endovascular tretment of other arteries at the same time, including vertebral arteries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radial Versus Femoral Access For Carotid Artery Stenting In Patients With Carotid-Artery Stenosis ：a Prospective, Randomized, Multicenter, Noninferiority Trial
Background: For moderate to severe carotid artery atherosclerotic stenosis, in the past decades, carotid artery stenting (CAS) has been an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. The transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for CAS. The radial artery is an ideal puncture site for cerebrovascular intervention. Studies have shown that nerve intervention through radial artery approach can complete most cerebrovascular intervention procedures, including cerebral angiography, carotid artery stent implantation, vertebral artery stent implantation, intracranial artery stent implantation, mechanical thrombectomy, aspiration, intra-arterial thrombolysis and so on. However, the current studies are based on single center small sample studies, and there has been still a lack of large sample randomized controlled experiments to verify the safety and effectiveness of CAS in transradial artery (TRA) .
Objective: To evaluate the efficacy and safety of CAS via TRA in patients with carotid artery stenosis through a multicenter, prospective and randomized study.
Read more
Study design: This study is a randomized, open label, multicenter, parallel controlled trial. A non-inferiority test is performed to compare the primary end point between the experimental group and the control group. The experimental group will undergo carotid stent implantation via radial artery approach, while the control group will use femoral artery approach.
Study population: Adult patients with symptomatic carotid-artery stenosis ≥50% or asymptomatic stenosis ≥70%.
Study outcomes: Primary end points: The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure Secondary end points:1.The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 48 hours post-procedure. 2. The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure. 3. The incidence of death within 48 hours / 30 days post-procedure. 4. The incidence of new-onset stroke within 48 hours / 30 days post-procedure. 5. The incidence of myocardial infarction within 48 hours / 30 days post-procedure. 6. The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure. Other end points: 1. Successful rate of cerebral angiography. 2. Successful rate of CAS. 3. Degree of patient-reported comfort. 4. Operation time. 5. NIHSS score changes within 5-7 days post-procedure. 6. mRS score score within 30 days post-procedure. Safety outcomes: 1.Occurrence of all adverse events. 2. AEs related to operation and device. 3. Incidence of adverse event of special interest.
- Being tested
- Carotid Artery Stenting (CAS)
- Medical subject headings
- Ischemic Stroke, Carotid Stenosis, Carotid Artery Diseases
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 insertion of a catheter or tube into an artery in the groin or the radial, and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. A stent is then placed to cover the plaque and hold the artery open.
| Study group | Role | What they receive |
|---|---|---|
| Transradial artery | Active comparator | Carotid stent implantation via radial artery approach Receives: Procedure: Carotid Artery Stenting (CAS) |
| Transfemoral artery | Active comparator | Carotid stent implantation via femoral artery approach Receives: Procedure: Carotid Artery Stenting (CAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure
The composite end point event is defined as any one of death, new-onset stroke, myocardial infarction, and severe hemorrhage events within 30 days.
Measured: 30 days
Secondary outcomes (6)
The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 48 hours post-procedure
The composite end point event is defined as any one of death, new-onset stroke, myocardial infarction, and severe hemorrhage events within 48 hours
Measured: 48 hours
The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure
The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure
Measured: 48 hours / 30 days
The incidence of death within 48 hours / 30 days post-procedure
The incidence of death within 48 hours / 30 days post-procedure
Measured: 48 hours / 30 days
The incidence of new-onset stroke within 48 hours / 30 days post-procedure
The incidence of new-onset stroke within 48 hours / 30 days post-procedure
Measured: 48 hours / 30 days
The incidence of myocardial infarction within 48 hours / 30 days post-procedure
The incidence of myocardial infarction within 48 hours / 30 days post-procedure
Measured: 48 hours / 30 days
The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure
The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure
Measured: 48 hours / 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start4 Jul 2022
- Primary completion24 Mar 2025
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416853
- Sponsor's protocol ID
- 2022-ky123
- Acronym
- RACE-CAS
- Status last verified
- Jul 2026
- First submitted
- 6 Jun 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4.
PubMed 28052979GBD 2016 Lifetime Risk of Stroke Collaborators; Feigin VL, Nguyen G, Cercy K, Johnson CO, Alam T, Parmar PG, Abajobir AA, Abate KH, Abd-Allah F, Abejie AN, Abyu GY, Ademi Z, Agarwal G, Ahmed MB, Akinyemi RO, Al-Raddadi R, Aminde LN, Amlie-Lefond C, Ansari H, Asayesh H, Asgedom SW, Atey TM, Ayele HT, Banach M, Banerjee A, Barac A, Barker-Collo SL, Barnighausen T, Barregard L, Basu S, Bedi N, Behzadifar M, Bejot Y, Bennett DA, Bensenor IM, Berhe DF, Boneya DJ, Brainin M, Campos-Nonato IR, Caso V, Castaneda-Orjuela CA, Rivas JC, Catala-Lopez F, Christensen H, Criqui MH, Damasceno A, Dandona L, Dandona R, Davletov K, de Courten B, deVeber G, Dokova K, Edessa D, Endres M, Faraon EJA, Farvid MS, Fischer F, Foreman K, Forouzanfar MH, Gall SL, Gebrehiwot TT, Geleijnse JM, Gillum RF, Giroud M, Goulart AC, Gupta R, Gupta R, Hachinski V, Hamadeh RR, Hankey GJ, Hareri HA, Havmoeller R, Hay SI, Hegazy MI, Hibstu DT, James SL, Jeemon P, John D, Jonas JB, Jozwiak J, Kalani R, Kandel A, Kasaeian A, Kengne AP, Khader YS, Khan AR, Khang YH, Khubchandani J, Kim D, Kim YJ, Kivimaki M, Kokubo Y, Kolte D, Kopec JA, Kosen S, Kravchenko M, Krishnamurthi R, Kumar GA, Lafranconi A, Lavados PM, Legesse Y, Li Y, Liang X, Lo WD, Lorkowski S, Lotufo PA, Loy CT, Mackay MT, Abd El Razek HM, Mahdavi M, Majeed A, Malekzadeh R, Malta DC, Mamun AA, Mantovani LG, Martins SCO, Mate KK, Mazidi M, Mehata S, Meier T, Melaku YA, Mendoza W, Mensah GA, Meretoja A, Mezgebe HB, Miazgowski T, Miller TR, Ibrahim NM, Mohammed S, Mokdad AH, Moosazadeh M, Moran AE, Musa KI, Negoi RI, Nguyen M, Nguyen QL, Nguyen TH, Tran TT, Nguyen TT, Anggraini Ningrum DN, Norrving B, Noubiap JJ, O'Donnell MJ, Olagunju AT, Onuma OK, Owolabi MO, Parsaeian M, Patton GC, Piradov M, Pletcher MA, Pourmalek F, Prakash V, Qorbani M, Rahman M, Rahman MA, Rai RK, Ranta A, Rawaf D, Rawaf S, Renzaho AM, Robinson SR, Sahathevan R, Sahebkar A, Salomon JA, Santalucia P, Santos IS, Sartorius B, Schutte AE, Sepanlou SG, Shafieesabet A, Shaikh MA, Shamsizadeh M, Sheth KN, Sisay M, Shin MJ, Shiue I, Silva DAS, Sobngwi E, Soljak M, Sorensen RJD, Sposato LA, Stranges S, Suliankatchi RA, Tabares-Seisdedos R, Tanne D, Nguyen CT, Thakur JS, Thrift AG, Tirschwell DL, Topor-Madry R, Tran BX, Nguyen LT, Truelsen T, Tsilimparis N, Tyrovolas S, Ukwaja KN, Uthman OA, Varakin Y, Vasankari T, Venketasubramanian N, Vlassov VV, Wang W, Werdecker A, Wolfe CDA, Xu G, Yano Y, Yonemoto N, Yu C, Zaidi Z, El Sayed Zaki M, Zhou M, Ziaeian B, Zipkin B, Vos T, Naghavi M, Murray CJL, Roth GA. Global, Regional, and Country-Specific Lifetime Risks of Stroke, 1990 and 2016. N Engl J Med. 2018 Dec 20;379(25):2429-2437. doi: 10.1056/NEJMoa1804492.
PubMed 30575491Ferguson GG, Eliasziw M, Barr HW, Clagett GP, Barnes RW, Wallace MC, Taylor DW, Haynes RB, Finan JW, Hachinski VC, Barnett HJ. The North American Symptomatic Carotid Endarterectomy Trial : surgical results in 1415 patients. Stroke. 1999 Sep;30(9):1751-8. doi: 10.1161/01.str.30.9.1751.
PubMed 10471419Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995 May 10;273(18):1421-8.
PubMed 7723155Gurm HS, Yadav JS, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Ansel G, Strickman NE, Wang H, Cohen SA, Massaro JM, Cutlip DE; SAPPHIRE Investigators. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med. 2008 Apr 10;358(15):1572-9. doi: 10.1056/NEJMoa0708028.
PubMed 18403765Silver B. Stenting versus endarterectomy for carotid-artery stenosis. N Engl J Med. 2010 Oct 28;363(18):1767-8; author reply 1768. doi: 10.1056/NEJMc1009626. No abstract available.
PubMed 21038512Feldman DN, Swaminathan RV, Kaltenbach LA, Baklanov DV, Kim LK, Wong SC, Minutello RM, Messenger JC, Moussa I, Garratt KN, Piana RN, Hillegass WB, Cohen MG, Gilchrist IC, Rao SV. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national cardiovascular data registry (2007-2012). Circulation. 2013 Jun 11;127(23):2295-306. doi: 10.1161/CIRCULATIONAHA.112.000536.
PubMed 23753843Khanna O, Sweid A, Mouchtouris N, Shivashankar K, Xu V, Velagapudi L, Stricsek G, Amllay A, Texakalidis P, Gooch MR, Tjoumakaris S, Rosenwasser RH, Jabbour PM. Radial Artery Catheterization for Neuroendovascular Procedures. Stroke. 2019 Sep;50(9):2587-2590. doi: 10.1161/STROKEAHA.119.025811. Epub 2019 Jul 17.
PubMed 31311466Ruzsa Z, Nemes B, Pinter L, Berta B, Toth K, Teleki B, Nardai S, Jambrik Z, Szabo G, Kolvenbach R, Huttl K, Merkely B. A randomised comparison of transradial and transfemoral approach for carotid artery stenting: RADCAR (RADial access for CARotid artery stenting) study. EuroIntervention. 2014 Jul;10(3):381-91. doi: 10.4244/EIJV10I3A64.
PubMed 25042266Liu R, Yuan K, Liu X, Sun W, Huang X, Wang H, Yi T, Liu X, Yin Q, Ye R, Ma M, Zhu W, Liu X. Radial Versus Femoral Access for Carotid Artery Stenting in Patients With Carotid Artery Stenosis: Protocol of the Multicenter RACE-CAS Randomized Trial. Stroke Vasc Interv Neurol. 2026 Sep 8;6(5):e002482. doi: 10.1161/SVIN.126.002482. eCollection 2026 Sep.
PubMed 42707800
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Versus Femoral Access For Carotid Artery Stenting In Patients With Carotid-Artery Stenosis ：a Prospective, Randomized, Multicenter, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT05416853
- Acronym / sponsor ID
- RACE-CAS / 2022-ky123
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 14 Jun 2022 (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.
Background: For moderate to severe carotid artery atherosclerotic stenosis, in the past decades, carotid artery stenting (CAS) has been an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. The transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for CAS. The radial artery is an ideal puncture site for cerebrovascular intervention. Studies have shown that nerve intervention through radial artery approach can complete most cerebrovascular intervention procedures, including cerebral angiography, carotid artery stent implantation, vertebral artery stent implantation, intracranial artery stent implantation, mechanical thrombectomy, aspiration, intra-arterial thrombolysis and so on. However, the current studies are based on single center small sample studies, and there has been still a lack of large sample randomized controlled experiments to verify the safety and effectiveness of CAS in transradial artery (TRA) .
Objective: To evaluate the efficacy and safety of CAS via TRA in patients with carotid artery stenosis through a multicenter, prospective and randomized study.
Study design: This study is a randomized, open label, multicenter, parallel controlled trial. A non-inferiority test is performed to compare the primary end point between the experimental group and the control group. The experimental group will undergo carotid stent implantation via radial artery approach, while the control group will use femoral artery approach.
Study population: Adult patients with symptomatic carotid-artery stenosis ≥50% or asymptomatic stenosis ≥70%.
Study outcomes: Primary end points: The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure Secondary end points:1.The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 48 hours post-procedure. 2. The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure. 3. The incidence of death within 48 hours / 30 days post-procedure. 4. The incidence of new-onset stroke within 48 hours / 30 days post-procedure. 5. The incidence of myocardial infarction within 48 hours / 30 days post-procedure. 6. The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure. Other end points: 1. Successful rate of cerebral angiography. 2. Successful rate of CAS. 3. Degree of patient-reported comfort. 4. Operation time. 5. NIHSS score changes within 5-7 days post-procedure. 6. mRS score score within 30 days post-procedure. Safety outcomes: 1.Occurrence of all adverse events. 2. AEs related to operation and device. 3. Incidence of adverse event of special interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transradial artery | Active comparator | Procedure: Carotid Artery Stenting (CAS)Carotid stent implantation via radial artery approach |
| Transfemoral artery | Active comparator | Procedure: Carotid Artery Stenting (CAS)Carotid stent implantation via femoral artery approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- General inclusion criteria
- 1) Age≥18 years old
- Clinical inclusion criteria
- Vascular inclusion criteria
Key exclusion criteria (23 listed)
- General exclusion criteria
- Vascular exclusion criteria
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 insertion of a catheter or tube into an artery in the groin or the radial, and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. A stent is then placed to cover the plaque and hold the artery open. | Procedure or surgery | Transfemoral artery, Transradial artery |
Primary outcome
The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure
Time frame: 30 days
The composite end point event is defined as any one of death, new-onset stroke, myocardial infarction, and severe hemorrhage events within 30 days.
6 secondary outcomes
The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 48 hours post-procedure
Time frame: 48 hours
The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure
Time frame: 48 hours / 30 days
The incidence of death within 48 hours / 30 days post-procedure
Time frame: 48 hours / 30 days
The incidence of new-onset stroke within 48 hours / 30 days post-procedure
Time frame: 48 hours / 30 days
The incidence of myocardial infarction within 48 hours / 30 days post-procedure
Time frame: 48 hours / 30 days
The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure
Time frame: 48 hours / 30 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 28 Jul 2026.
- Results publication: PubMed 28052979Wang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4.
- Results publication: PubMed 30575491GBD 2016 Lifetime Risk of Stroke Collaborators; Feigin VL, Nguyen G, Cercy K, Johnson CO, Alam T, Parmar PG, Abajobir AA, Abate KH, Abd-Allah F, Abejie AN, Abyu GY, Ademi Z, Agarwal G, Ahmed MB, Akinyemi RO, Al-Raddadi R, Aminde LN, Amlie-Lefond C, Ansari H, Asayesh H, Asgedom SW, Atey TM, Ayele HT, Banach M, Banerjee A, Barac A, Barker-Collo SL, Barnighausen T, Barregard L, Basu S, Bedi N, Behzadifar M, Bejot Y, Bennett DA, Bensenor IM, Berhe DF, Boneya DJ, Brainin M, Campos-Nonato IR, Caso V, Castaneda-Orjuela CA, Rivas JC, Catala-Lopez F, Christensen H, Criqui MH, Damasceno A, Dandona L, Dandona R, Davletov K, de Courten B, deVeber G, Dokova K, Edessa D, Endres M, Faraon EJA, Farvid MS, Fischer F, Foreman K, Forouzanfar MH, Gall SL, Gebrehiwot TT, Geleijnse JM, Gillum RF, Giroud M, Goulart AC, Gupta R, Gupta R, Hachinski V, Hamadeh RR, Hankey GJ, Hareri HA, Havmoeller R, Hay SI, Hegazy MI, Hibstu DT, James SL, Jeemon P, John D, Jonas JB, Jozwiak J, Kalani R, Kandel A, Kasaeian A, Kengne AP, Khader YS, Khan AR, Khang YH, Khubchandani J, Kim D, Kim YJ, Kivimaki M, Kokubo Y, Kolte D, Kopec JA, Kosen S, Kravchenko M, Krishnamurthi R, Kumar GA, Lafranconi A, Lavados PM, Legesse Y, Li Y, Liang X, Lo WD, Lorkowski S, Lotufo PA, Loy CT, Mackay MT, Abd El Razek HM, Mahdavi M, Majeed A, Malekzadeh R, Malta DC, Mamun AA, Mantovani LG, Martins SCO, Mate KK, Mazidi M, Mehata S, Meier T, Melaku YA, Mendoza W, Mensah GA, Meretoja A, Mezgebe HB, Miazgowski T, Miller TR, Ibrahim NM, Mohammed S, Mokdad AH, Moosazadeh M, Moran AE, Musa KI, Negoi RI, Nguyen M, Nguyen QL, Nguyen TH, Tran TT, Nguyen TT, Anggraini Ningrum DN, Norrving B, Noubiap JJ, O'Donnell MJ, Olagunju AT, Onuma OK, Owolabi MO, Parsaeian M, Patton GC, Piradov M, Pletcher MA, Pourmalek F, Prakash V, Qorbani M, Rahman M, Rahman MA, Rai RK, Ranta A, Rawaf D, Rawaf S, Renzaho AM, Robinson SR, Sahathevan R, Sahebkar A, Salomon JA, Santalucia P, Santos IS, Sartorius B, Schutte AE, Sepanlou SG, Shafieesabet A, Shaikh MA, Shamsizadeh M, Sheth KN, Sisay M, Shin MJ, Shiue I, Silva DAS, Sobngwi E, Soljak M, Sorensen RJD, Sposato LA, Stranges S, Suliankatchi RA, Tabares-Seisdedos R, Tanne D, Nguyen CT, Thakur JS, Thrift AG, Tirschwell DL, Topor-Madry R, Tran BX, Nguyen LT, Truelsen T, Tsilimparis N, Tyrovolas S, Ukwaja KN, Uthman OA, Varakin Y, Vasankari T, Venketasubramanian N, Vlassov VV, Wang W, Werdecker A, Wolfe CDA, Xu G, Yano Y, Yonemoto N, Yu C, Zaidi Z, El Sayed Zaki M, Zhou M, Ziaeian B, Zipkin B, Vos T, Naghavi M, Murray CJL, Roth GA. Global, Regional, and Country-Specific Lifetime Risks of Stroke, 1990 and 2016. N Engl J Med. 2018 Dec 20;379(25):2429-2437. doi: 10.1056/NEJMoa1804492.
- Results publication: PubMed 10471419Ferguson GG, Eliasziw M, Barr HW, Clagett GP, Barnes RW, Wallace MC, Taylor DW, Haynes RB, Finan JW, Hachinski VC, Barnett HJ. The North American Symptomatic Carotid Endarterectomy Trial : surgical results in 1415 patients. Stroke. 1999 Sep;30(9):1751-8. doi: 10.1161/01.str.30.9.1751.
- Results publication: PubMed 7723155Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995 May 10;273(18):1421-8.
- Results publication: PubMed 18403765Gurm HS, Yadav JS, Fayad P, Katzen BT, Mishkel GJ, Bajwa TK, Ansel G, Strickman NE, Wang H, Cohen SA, Massaro JM, Cutlip DE; SAPPHIRE Investigators. Long-term results of carotid stenting versus endarterectomy in high-risk patients. N Engl J Med. 2008 Apr 10;358(15):1572-9. doi: 10.1056/NEJMoa0708028.
- Results publication: PubMed 21038512Silver B. Stenting versus endarterectomy for carotid-artery stenosis. N Engl J Med. 2010 Oct 28;363(18):1767-8; author reply 1768. doi: 10.1056/NEJMc1009626. No abstract available.
- Results publication: PubMed 23753843Feldman DN, Swaminathan RV, Kaltenbach LA, Baklanov DV, Kim LK, Wong SC, Minutello RM, Messenger JC, Moussa I, Garratt KN, Piana RN, Hillegass WB, Cohen MG, Gilchrist IC, Rao SV. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national cardiovascular data registry (2007-2012). Circulation. 2013 Jun 11;127(23):2295-306. doi: 10.1161/CIRCULATIONAHA.112.000536.
- Results publication: PubMed 31311466Khanna O, Sweid A, Mouchtouris N, Shivashankar K, Xu V, Velagapudi L, Stricsek G, Amllay A, Texakalidis P, Gooch MR, Tjoumakaris S, Rosenwasser RH, Jabbour PM. Radial Artery Catheterization for Neuroendovascular Procedures. Stroke. 2019 Sep;50(9):2587-2590. doi: 10.1161/STROKEAHA.119.025811. Epub 2019 Jul 17.
- Results publication: PubMed 25042266Ruzsa Z, Nemes B, Pinter L, Berta B, Toth K, Teleki B, Nardai S, Jambrik Z, Szabo G, Kolvenbach R, Huttl K, Merkely B. A randomised comparison of transradial and transfemoral approach for carotid artery stenting: RADCAR (RADial access for CARotid artery stenting) study. EuroIntervention. 2014 Jul;10(3):381-91. doi: 10.4244/EIJV10I3A64.
- Derived from this study: PubMed 42707800Liu R, Yuan K, Liu X, Sun W, Huang X, Wang H, Yi T, Liu X, Yin Q, Ye R, Ma M, Zhu W, Liu X. Radial Versus Femoral Access for Carotid Artery Stenting in Patients With Carotid Artery Stenosis: Protocol of the Multicenter RACE-CAS Randomized Trial. Stroke Vasc Interv Neurol. 2026 Sep 8;6(5):e002482. doi: 10.1161/SVIN.126.002482. eCollection 2026 Sep.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid Artery Stenting (CAS) in people with Ischemic Stroke and Carotid Stenosis, run by The First Affiliated Hospital of University of Science and Technology of China 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 14 inclusion and 23 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 28 Jul 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?
The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure (time frame: 30 days). 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 NCT05416853, which also lists 10 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 28 Jul 2026.