Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2021-09-15
2023-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radial access
The ischemic stroke treatment will be performed through the radial artery (as first option)
thrombectomy
Extraction of intracranial thrombus in an acute large vessel occlusion
Femoral access
The ischemic stroke treatment will be performed through the femoral artery (as first option)
thrombectomy
Extraction of intracranial thrombus in an acute large vessel occlusion
Interventions
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thrombectomy
Extraction of intracranial thrombus in an acute large vessel occlusion
Eligibility Criteria
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Inclusion Criteria
* Immediate availability of the entire team responsible for endovascular treatment (Neurologist, Neurointerventional physician, Anesthetist, Nursing, Technicians ...)
* Radial artery diameter ≥2.5 mm
* Presence of femoral pulse or patency by ultrasonography in its defect.
* Previous functional independence (mRS 0-2).
Exclusion Criteria
* Intracranial hemorrhage
* Patients with pre-existing neurological or psychiatric pathology that may confuse future evaluations.
* No availability for follow-up after 90 days.
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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ALEJANDRO TOMASELLO, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Vall d'Hebron Research Institute
Locations
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Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.
Saver JL, Goyal M, van der Lugt A, Menon BK, Majoie CB, Dippel DW, Campbell BC, Nogueira RG, Demchuk AM, Tomasello A, Cardona P, Devlin TG, Frei DF, du Mesnil de Rochemont R, Berkhemer OA, Jovin TG, Siddiqui AH, van Zwam WH, Davis SM, Castano C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro A, Lingsma H, Silver FL, Donnan GA, Shuaib A, Brown S, Stouch B, Mitchell PJ, Davalos A, Roos YB, Hill MD; HERMES Collaborators. Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016 Sep 27;316(12):1279-88. doi: 10.1001/jama.2016.13647.
Mazighi M, Chaudhry SA, Ribo M, Khatri P, Skoloudik D, Mokin M, Labreuche J, Meseguer E, Yeatts SD, Siddiqui AH, Broderick J, Molina CA, Qureshi AI, Amarenco P. Impact of onset-to-reperfusion time on stroke mortality: a collaborative pooled analysis. Circulation. 2013 May 14;127(19):1980-5. doi: 10.1161/CIRCULATIONAHA.112.000311.
Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1.
Valgimigli M, Gagnor A, Calabro P, Frigoli E, Leonardi S, Zaro T, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Cortese B, Sganzerla P, Lupi A, Galli M, Colangelo S, Ierna S, Ausiello A, Presbitero P, Sardella G, Varbella F, Esposito G, Santarelli A, Tresoldi S, Nazzaro M, Zingarelli A, de Cesare N, Rigattieri S, Tosi P, Palmieri C, Brugaletta S, Rao SV, Heg D, Rothenbuhler M, Vranckx P, Juni P; MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015 Jun 20;385(9986):2465-76. doi: 10.1016/S0140-6736(15)60292-6. Epub 2015 Mar 16.
Chase AJ, Fretz EB, Warburton WP, Klinke WP, Carere RG, Pi D, Berry B, Hilton JD. Association of the arterial access site at angioplasty with transfusion and mortality: the M.O.R.T.A.L study (Mortality benefit Of Reduced Transfusion after percutaneous coronary intervention via the Arm or Leg). Heart. 2008 Aug;94(8):1019-25. doi: 10.1136/hrt.2007.136390. Epub 2008 Mar 10.
Bertrand OF, Belisle P, Joyal D, Costerousse O, Rao SV, Jolly SS, Meerkin D, Joseph L. Comparison of transradial and femoral approaches for percutaneous coronary interventions: a systematic review and hierarchical Bayesian meta-analysis. Am Heart J. 2012 Apr;163(4):632-48. doi: 10.1016/j.ahj.2012.01.015.
Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD012318. doi: 10.1002/14651858.CD012318.pub2.
Ghani MR, Busa V, Dardeir A, Marudhai S, Patel M, Abdelmoneim YM, Jan A, Eskander N. Mechanical Thrombectomy in Patients With Acute Ischemic Stroke: A Comparison of Transradial Versus Transfemoral Cerebral Angiography. Cureus. 2020 Oct 12;12(10):e10919. doi: 10.7759/cureus.10919.
Phillips TJ, Crockett MT, Selkirk GD, Kabra R, Chiu AHY, Singh T, Phatouros C, McAuliffe W. Transradial versus transfemoral access for anterior circulation mechanical thrombectomy: analysis of 375 consecutive cases. Stroke Vasc Neurol. 2021 Jun;6(2):207-213. doi: 10.1136/svn-2020-000624. Epub 2020 Nov 16.
Chen SH, Snelling BM, Sur S, Shah SS, McCarthy DJ, Luther E, Yavagal DR, Peterson EC, Starke RM. Transradial versus transfemoral access for anterior circulation mechanical thrombectomy: comparison of technical and clinical outcomes. J Neurointerv Surg. 2019 Sep;11(9):874-878. doi: 10.1136/neurintsurg-2018-014485. Epub 2019 Jan 22.
Khanna O, Mouchtouris N, Sweid A, Chalouhi N, Ghosh R, Al Saiegh F, Gooch MR, Tjoumakaris S, Rosenwasser RH, Romo V, Jabbour P. Transradial approach for acute stroke intervention: technical procedure and clinical outcomes. Stroke Vasc Neurol. 2019 Nov 27;5(1):103-106. doi: 10.1136/svn-2019-000263. eCollection 2020.
Crockett MT, Selkirk GD, Chiu AHY, Singh TP, McAuliffe W, Phillips TJ. First line transradial access for posterior circulation stroke intervention; initial 12-month experience at a high volume thrombectomy center. J Clin Neurosci. 2020 Aug;78:194-197. doi: 10.1016/j.jocn.2020.04.069. Epub 2020 Apr 23.
Maud A, Khatri R, Chaudhry MRA, Vellipuram A, Cruz-Flores S, Rodriguez GJ. Transradial Access Results in Faster Skin Puncture to Reperfusion Time than Transfemoral Access in Posterior Circulation Mechanical Thrombectomy. J Vasc Interv Neurol. 2019 May;10(3):53-57.
Khanna 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.
Amoroso G, Sarti M, Bellucci R, Puma FL, D'Alessandro S, Limbruno U, Canova A, Petronio AS. Clinical and procedural predictors of nurse workload during and after invasive coronary procedures: the potential benefit of a systematic radial access. Eur J Cardiovasc Nurs. 2005 Sep;4(3):234-41. doi: 10.1016/j.ejcnurse.2005.03.005.
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.
Other Identifiers
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PR(AG)209/2021
Identifier Type: -
Identifier Source: org_study_id
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