Brachial Versus Femoral Access for Carotid Artery Stenting

NCT06557135 | Recruiting DMC

• 1 other identifier: 2024-SR-534
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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. Primary endpoint: surgical success rate. Secondary endpoints:

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

Conditions

Carotid Artery Stenosis Without Infarction (Disorder); Ischemic Stroke

Keywords

Brachial Artery; Femoral Artery; Carotid Artery Stenting; Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

• 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%.

  24 hours

Secondary Outcomes (3)

• Procedure time

  24 hours

• Serious adverse events (SAE)

  90 days

• Access puncture complications

  90 days

Other Outcomes (3)

• X-ray exposure

  24 hours

• Access conversion

  24 hours

• Degree of patient-reported comfort

  24 hours

Study Arms (2)

the brachial group

EXPERIMENTAL

Patients with carotid artery stenosis will be randomly selected for carotid artery stenting via the brachial artery access.

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.

Procedure: Carotid Artery Stenting (CAS)

Interventions

Carotid Artery Stenting (CAS) PROCEDURE

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.

the brachial group; the femoral group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (13)

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  PMID: 30165632 BACKGROUND

• 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.

  PMID: 33191571 BACKGROUND

• 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.

  PMID: 31974282 BACKGROUND

• 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.

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• 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.

  PMID: 36519647 BACKGROUND

• 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.

  PMID: 32819794 BACKGROUND

• 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.

  PMID: 31818970 BACKGROUND

• 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.

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  PMID: 16291435 BACKGROUND

• 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.

  PMID: 33632887 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 38299334 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Carotid Stenosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Arterial Occlusive Diseases

Study Officials

• Sheng Liu, Professor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

kai Qiu, Doctor

CONTACT

+8615895907771; 2232723655@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 16, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)