Ischemic Stroke, AcuteSFERANCT05225636
Stroke Process in FEmoral Versus Radial Access
A study testing thrombectomy in people with Ischemic Stroke, Acute, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
Trial summary
In patients with suspected acute stroke due to large vessel occlusion with indication for endovascular treatment, radial access is just as safe, fast, and effective as femoral access, and it improves the entire stroke treatment process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Sep 2021to 28 Apr 2023
- 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
- Patients with high suspicion of ischemic stroke due to large cerebral vessel occlusion defined by NIHSS> 10.
- 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).
Who cannot join
- Life expectancy of less than 6 months.
- Intracranial hemorrhage
- Patients with pre-existing neurological or psychiatric pathology that may confuse future evaluations.
- No availability for follow-up after 90 days.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Barcelona, 08035
Alejandro Tomasello, MD, 934893000 ext. 6441, alejandrotomasello@gmail.com
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Alejandro Tomasello, MD, 93489300 ext. 6441, alejandrotomasello@gmail.com
David Hernandez, MD, 93489300 ext. 6748, dhm050780@gmail.com
About this study
In patients with suspected acute stroke due to large vessel occlusion with indication for endovascular treatment, radial access is just as safe, fast, and effective as femoral access, and it improves the entire stroke treatment process.
Read the detailed description
Investigators will compare the procedure times, angiographic results as well as the clinical evolution and the patient's experience during their hospital stay and after discharge, depending on the arterial access practiced for mechanical thrombectomy.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- thrombectomy
- Keywords
- Radial access, Femoral access, Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombectomyProcedure or surgery
Extraction of intracranial thrombus in an acute large vessel occlusion
| Study group | Role | What they receive |
|---|---|---|
| Radial access | Active comparator | The ischemic stroke treatment will be performed through the radial artery (as first option) Receives: Procedure: thrombectomy |
| Femoral access | Active comparator | The ischemic stroke treatment will be performed through the femoral artery (as first option) Receives: Procedure: thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
No inferiority of radial access in the recanalization rate
To demonstrate the non-inferiority of radial access with respect to femoral access in the recanalization rate (% mTICI 2b-3 in 3 or fewer passes) obtained in patients with large vessel occlusion treated by mechanical thrombectomy.
Measured: Immediate after treatment
Secondary outcomes (7)
No differences in complications in vascular access
Comparison in frequency of access vessel occlusion, bleeding or presence of pseudoaneurysm
Measured: 24 hours
Grades of modified Thrombolysis in Cerebral Infarction
Grade of recanalization after first pass, third pass and at the end of the procedure
Measured: 24 hours
Change of artery access
Rate of need to change from radial to femoral access and from femoral to radial access
Measured: 24 hours
Patient Reported Outcomes
PROMS Patient Reported Outcomes Measures
Measured: 5 days
Patient experience
PREMS Patient Reported Experience Measures
Measured: 5 days
Degree of disability/dependence after a stroke
modified rankin scale (from 0 to 6, being 0 best and 6 worst)
Measured: 24 hours and at 90 days
Times during hospitalization
Beginning of sitting, ambulation, rehabilitation and total time of hospital admission, need for urinary catheter
Measured: At 24 hours and during first 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start15 Sep 2021
- Primary completion15 Jan 2023 (estimated)
- Study completion28 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Model description
- Randomized, prospective clinical trial, under conditions of routine, open-label clinical practice, with the main objective evaluated by an independent investigator who was not blinded to the treatment received. The study will be single-center.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ALEJANDRO TOMASELLO, MD, Principal investigator, Hospital Universitari Vall d'Hebron Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225636
- Sponsor's protocol ID
- PR(AG)209/2021
- Acronym
- SFERA
- Status last verified
- Jan 2022
- First submitted
- 27 Aug 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After finishing the study we will share all the data if a collaboration is proposed
Publications
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.
PubMed 26898852Saver 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.
PubMed 27673305Mazighi 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.
PubMed 23671178Jolly 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.
PubMed 19081409Valgimigli 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.
PubMed 25791214Chase 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.
PubMed 18332059Bertrand 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.
PubMed 22520530Kolkailah 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.
PubMed 29665617Ghani 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.
PubMed 33194486Phillips 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.
PubMed 33199413Chen 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.
PubMed 30670623Khanna 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.
PubMed 32411415Crockett 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.
PubMed 32336634Maud 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.
PubMed 31308872Khanna 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 31311466
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Process in FEmoral Versus Radial Access
- ClinicalTrials.gov ID
- NCT05225636
- Acronym / sponsor ID
- SFERA / PR(AG)209/2021
- Conditions
- Ischemic Stroke, Acute
- Keywords
- Radial access, Femoral access, Thrombectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 28 Apr 2023 (estimated)
- First posted
- 4 Feb 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.
In patients with suspected acute stroke due to large vessel occlusion with indication for endovascular treatment, radial access is just as safe, fast, and effective as femoral access, and it improves the entire stroke treatment process.
Detailed description
Investigators will compare the procedure times, angiographic results as well as the clinical evolution and the patient's experience during their hospital stay and after discharge, depending on the arterial access practiced for mechanical thrombectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, prospective clinical trial, under conditions of routine, open-label clinical practice, with the main objective evaluated by an independent investigator who was not blinded to the treatment received. The study will be single-center.
| Arm | Type | Receives |
|---|---|---|
| Radial access | Active comparator | Procedure: thrombectomyThe ischemic stroke treatment will be performed through the radial artery (as first option) |
| Femoral access | Active comparator | Procedure: thrombectomyThe ischemic stroke treatment will be performed through the femoral artery (as first option) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with high suspicion of ischemic stroke due to large cerebral vessel occlusion defined by NIHSS> 10.
- 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).
Key exclusion criteria (4 listed)
- Life expectancy of less than 6 months.
- Intracranial hemorrhage
- Patients with pre-existing neurological or psychiatric pathology that may confuse future evaluations.
- No availability for follow-up after 90 days.
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 |
|---|---|---|
| thrombectomyExtraction of intracranial thrombus in an acute large vessel occlusion | Procedure or surgery | Femoral access, Radial access |
Primary outcome
No inferiority of radial access in the recanalization rate
Time frame: Immediate after treatment
To demonstrate the non-inferiority of radial access with respect to femoral access in the recanalization rate (% mTICI 2b-3 in 3 or fewer passes) obtained in patients with large vessel occlusion treated by mechanical thrombectomy.
7 secondary outcomes
No differences in complications in vascular access
Time frame: 24 hours
Grades of modified Thrombolysis in Cerebral Infarction
Time frame: 24 hours
Change of artery access
Time frame: 24 hours
Patient Reported Outcomes
Time frame: 5 days
Patient experience
Time frame: 5 days
Degree of disability/dependence after a stroke
Time frame: 24 hours and at 90 days
Times during hospitalization
Time frame: At 24 hours and during first 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Background: PubMed 26898852Goyal 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.
- Background: PubMed 27673305Saver 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.
- Background: PubMed 23671178Mazighi 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.
- Background: PubMed 19081409Jolly 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.
- Background: PubMed 25791214Valgimigli 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.
- Background: PubMed 18332059Chase 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.
- Background: PubMed 22520530Bertrand 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.
- Background: PubMed 29665617Kolkailah 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.
- Background: PubMed 33194486Ghani 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.
- Background: PubMed 33199413Phillips 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.
- Background: PubMed 30670623Chen 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.
- Background: PubMed 32411415Khanna 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.
- Individual participant dataSharing planned: Yes. After finishing the study we will share all the data if a collaboration is proposed
Related trials for Ischemic Stroke, Acute
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 2
The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients
Acute Ischemic Stroke
Not yet recruiting
Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy
Acute Ischemic Stroke
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.
ALEJANDRO TOMASELLO, MD principal investigator
Hospital Universitari Vall d'Hebron Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thrombectomy in people with Ischemic Stroke, Acute, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DAVID HERNANDEZ, MD (+34934893000 ext. 6441, dhm050780@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No inferiority of radial access in the recanalization rate (time frame: Immediate after treatment). 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 NCT05225636, which also lists 17 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 4 Feb 2022.