Basilar Artery ThrombosisBASICSNCT01717755
Basilar Artery International Cooperation Study
A study testing Intra-arterial treatment in people with Basilar Artery Thrombosis and Basilar Artery Embolism, run by Erik van der Hoeven at 27 sites in 6 countries.
Trial summary
Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basilar Artery Thrombosis, Basilar Artery Embolism, Stroke of Basilar Artery
- What is being tested?
- Intra-arterial treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 27 sitesin 6 countries
- Study dates
- Oct 2011to Jan 2020
- 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
- Symptoms and signs compatible with ischemia in the basilar artery territory.
- Basilar artery occlusion (BAO) confirmed by CTA or MRA.
- Age 18 years or older (i.e., candidates must have had their 18th birthday).
- If IVT is considered as part of best medical management, IVT should be started within 4.5 hours of estimated time of BAO. (Estimated time of BAO is defined as time of onset of acute symptoms leading to clinical diagnosis of BAO or if not known last time patient was seen normal prior to onset of these symptoms).
- Initiation of IAT should be feasible within 6 hours of estimated time of BAO.
Who cannot join
- Pre-existing dependency with mRankin ≥3.
- Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
- Patients who require hemodialysis or peritoneal dialysis.
- Other serious, advanced, or terminal illness.
- Any other condition that the investigator feels would pose a significant hazard to the patient if thrombolytic therapy is initiated.
- Current participation in another research drug treatment protocol (patient cannot start another experimental agent until after 90 days).
Show all 11Show fewer
- Informed consent is not or cannot be obtained.
- Imaging exclusion criteria
- High-density lesion consistent with hemorrhage of any degree.
- Significant cerebellar mass effect or acute hydrocephalus.
- Bilateral extended brainstem ischemia.
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
Netherlands11 sites, 9 recruiting
- Recruiting
Academic Medical Center
Amsterdam, North Holland, 1105AZ
Paul Nederkoorn, MD, PhD
- Suspended
Rijnstate
Arnhem, Gelderland, 6800 TA
- Withdrawn
University Medical Center Groningen
Groningen
- Recruiting
Leiden University Hospital
Leiden
Marieke Wermer, MD, PhD
- Recruiting
Academic Hospital Maastricht
Maastricht, Limburg, 6229 HX
Julie Staals, MD, PhD
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3430 EM
Wouter Schonewille, MD, PhD
- Recruiting
Erasmus Medical Center
Rotterdam
Diederik Dippel
- Recruiting
MCH Westeinde
The Hague, South Holland, 2512 VA
Jelis Boiten, MD, PhD
- Recruiting
Haga Hospital
The Hague
Karlijn de Laat, MD, PhD
- Recruiting
St. Elisabeth Hospital
Tilburg, North Brabant, 5022 GC
Paul de Kort, MD, PhD
- Recruiting
Universitary Medical Center Utrecht
Utrecht, 3584 CX
Jaap Kappelle, MD, PhD
Italy6 sites, 5 recruiting
- Recruiting
Bergamo Hospital
Bergamo
Bruno Censori, MD, PhD
- Recruiting
Genova Hospital
Genoa
Laura Malfatto, MD, PhD
- Recruiting
University Hospital Modena
Modena, 41100
Andrea Zini, MD, PhD
- Recruiting
Santa Corona Hospital
Pietra Ligure
T. Tassinari
- Withdrawn
Roma Umberto I
Rome
- Recruiting
Varese Hospital
Varese
M.L. DeLodovici, MD, PhD
Germany5 sites, 3 recruiting
- Recruiting
Klinikum Augsburg
Augsburg
Hauke Schneider
- Recruiting
Berlin Charite Hospital
Berlin
Heinrich Audebert, MD, PhD
- Recruiting
Dresden University Hospital
Dresden
Volker Puetz, MD, PhD
- Terminated
University Medical Center Mannheim
Mannheim
- Terminated
Oberschwabenklinik
Ravensburg
Brazil2 sites, 2 recruiting
- Recruiting
Fortaleza General Hospital
Fortaleza
F Mont Alverne
- Recruiting
Hospital das Clinicas de Ribeirao Preto
Ribeirão Preto
O Pontes Neto
Norway2 sites, 2 recruiting
- Recruiting
University Hospital North Norway
Tromsø
Stein Harald Johnsen
- Recruiting
St. Olavs Hospital Trondheim
Trondheim
Gitta Rohweder, MD, PhD
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Lausanne
Lausanne, Canton of Vaud, CH-1011
Patrik Michel, MD, PhD
About this study
Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.
Objective: Evaluate the efficacy and safety of IAT in addition to best medical management (BMM) in patients with basilar artery occlusion.
Read more
Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.
Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar occlusion.
Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone. IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.
Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
- Conditions
- Basilar Artery Thrombosis, Basilar Artery Embolism, Stroke of Basilar Artery, Stroke, Cerebrovascular Disorders, Basilar Artery Occlusion
- Being tested
- Intra-arterial treatment
- Keywords
- basilar, stroke, mechanical, thrombolysis, intra-arterial, trombectomy
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial treatmentOther
IA therapy has to be initiated within 6 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of IA strategy wil be made by the treating neurointerventionalist. Choice of therapy depends on local approval and experience. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a high-grade vertebral artery stenosis or occlusion hampering adequate endovascular access to the basilar artery and in case of a residual high-grade basilar artery stenosis. The use of any other treatment strategy depends on local approval and experience, and is only allowed after prior approval of the steering committee.
| Study group | Role | What they receive |
|---|---|---|
| Best medical management. | No intervention | Best medical management consists of the standard of care of patients with acute ischemic stroke according to existing local protocols and guidelines, and may include IV thrombolysis. If treated with IVT as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO. |
| Additional intra-arterial treatment. | Experimental | Best medical management followed by intra-arterial treatment and best medical management Receives: Other: Intra-arterial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favourable outcome
Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
Measured: day 90
Secondary outcomes (4)
Excellent outcome
Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
Measured: day 90
Modified Rankin Score
Modified Rankin Score - not dichotomized.
Measured: day 90
NIHSS
National Institutes of Health Stroke Scale (NIHSS - acute assessment scale) at timepoints:
- directly pre intravenous thrombolysis
- directly pre randomization (post intravenous thrombolysis)
- at 24 hours +- 6 hours post treatment.
Measured: pre IVT, pre randomization, 24h post treatment
EQ-5D
EQ-5D (quality of life) at day 90 and at 12 months.
Measured: day 90 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Basilar Artery ThrombosisStudies 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
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erik van der Hoeven
- Sponsor type
- University, hospital or other
- Collaborators
- BASICS Study Group
- Responsible party
- Sponsor-investigator, Erik van der Hoeven, St. Antonius Hospital
- Investigators
- W J Schonewille, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717755
- Sponsor's protocol ID
- NL33550.100.10
- Other IDs
- NHS2010B151, 2010-023507-95
- Acronym
- BASICS
- Status last verified
- Jan 2018
- First submitted
- 23 Oct 2012
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schonewille WJ, Wijman CA, Michel P, Rueckert CM, Weimar C, Mattle HP, Engelter ST, Tanne D, Muir KW, Molina CA, Thijs V, Audebert H, Pfefferkorn T, Szabo K, Lindsberg PJ, de Freitas G, Kappelle LJ, Algra A; BASICS study group. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study. Lancet Neurol. 2009 Aug;8(8):724-30. doi: 10.1016/S1474-4422(09)70173-5. Epub 2009 Jul 3.
PubMed 19577962Greving JP, Schonewille WJ, Wijman CA, Michel P, Kappelle LJ, Algra A; BASICS Study Group. Predicting outcome after acute basilar artery occlusion based on admission characteristics. Neurology. 2012 Apr 3;78(14):1058-63. doi: 10.1212/WNL.0b013e31824e8f40. Epub 2012 Mar 21.
PubMed 22442438Vergouwen MD, Compter A, Tanne D, Engelter ST, Audebert H, Thijs V, de Freitas G, Algra A, Jaap Kappelle L, Schonewille WJ. Outcomes of basilar artery occlusion in patients aged 75 years or older in the Basilar Artery International Cooperation Study. J Neurol. 2012 Nov;259(11):2341-6. doi: 10.1007/s00415-012-6498-2. Epub 2012 Apr 18.
PubMed 22527236Puetz V, Khomenko A, Hill MD, Dzialowski I, Michel P, Weimar C, Wijman CA, Mattle HP, Engelter ST, Muir KW, Pfefferkorn T, Tanne D, Szabo K, Kappelle LJ, Algra A, von Kummer R, Demchuk AM, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Group. Extent of hypoattenuation on CT angiography source images in basilar artery occlusion: prognostic value in the Basilar Artery International Cooperation Study. Stroke. 2011 Dec;42(12):3454-9. doi: 10.1161/STROKEAHA.111.622175. Epub 2011 Sep 29.
PubMed 21960577Arnold M, Fischer U, Compter A, Gralla J, Findling O, Mattle HP, Kappelle LJ, Tanne D, Algra A, Schonewille WJ; BASICS Study Group. Acute basilar artery occlusion in the Basilar Artery International Cooperation Study: does gender matter? Stroke. 2010 Nov;41(11):2693-6. doi: 10.1161/STROKEAHA.110.594036. Epub 2010 Oct 14.
PubMed 20947845Schonewille WJ, Wijman CA, Michel P, Algra A, Kappelle LJ; BASICS Study Group. The basilar artery international cooperation study (BASICS). Int J Stroke. 2007 Aug;2(3):220-3. doi: 10.1111/j.1747-4949.2007.00145.x.
PubMed 18705948Schonewille W, Wijman C, Michel P; BASICS investigators. Treatment and clinical outcome in patients with basilar artery occlusion. Stroke. 2006 Sep;37(9):2206; author reply 2207. doi: 10.1161/01.STR.0000237127.84408.c0. Epub 2006 Aug 10. No abstract available.
PubMed 16902170Vergouwen MD, Algra A, Pfefferkorn T, Weimar C, Rueckert CM, Thijs V, Kappelle LJ, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Study Group. Time is brain(stem) in basilar artery occlusion. Stroke. 2012 Nov;43(11):3003-6. doi: 10.1161/STROKEAHA.112.666867. Epub 2012 Sep 18.
PubMed 22989501Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.
PubMed 34125952Langezaal LCM, van der Hoeven EJRJ, Mont'Alverne FJA, de Carvalho JJF, Lima FO, Dippel DWJ, van der Lugt A, Lo RTH, Boiten J, Lycklama A Nijeholt GJ, Staals J, van Zwam WH, Nederkoorn PJ, Majoie CBLM, Gerber JC, Mazighi M, Piotin M, Zini A, Vallone S, Hofmeijer J, Martins SO, Nolte CH, Szabo K, Dias FA, Abud DG, Wermer MJH, Remmers MJM, Schneider H, Rueckert CM, de Laat KF, Yoo AJ, van Doormaal PJ, van Es ACGM, Emmer BJ, Michel P, Puetz V, Audebert HJ, Pontes-Neto OM, Vos JA, Kappelle LJ, Algra A, Schonewille WJ; BASICS Study Group. Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion. N Engl J Med. 2021 May 20;384(20):1910-1920. doi: 10.1056/NEJMoa2030297.
PubMed 34010530van der Hoeven EJ, Schonewille WJ, Vos JA, Algra A, Audebert HJ, Berge E, Ciccone A, Mazighi M, Michel P, Muir KW, Obach V, Puetz V, Wijman CA, Zini A, Kappelle JL; BASICS Study Group. The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial. Trials. 2013 Jul 8;14:200. doi: 10.1186/1745-6215-14-200.
PubMed 23835026
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basilar Artery International Cooperation Study
- ClinicalTrials.gov ID
- NCT01717755
- Acronym / sponsor ID
- BASICS / NL33550.100.10
- Conditions
- Basilar Artery Thrombosis, Basilar Artery Embolism, Stroke of Basilar Artery, Stroke, Cerebrovascular Disorders, Basilar Artery Occlusion
- Keywords
- basilar, stroke, mechanical, thrombolysis, intra-arterial, trombectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Erik van der HoevenUniversity, hospital or other
- Collaborators
- BASICS Study Group
- Study start
- Oct 2011
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 30 Oct 2012 (estimated)
- 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.
Rationale: Recently our study group reported the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute symptomatic BAO is challenged by our data. The BASICS registry was observational and has all the limitations of a non-randomised study. Interpretation of results is hampered by the lack of a standard treatment protocol for all patients who entered the study.
Objective: Evaluate the efficacy and safety of IAT in addition to best medical management (BMM) in patients with basilar artery occlusion.
Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.
Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar occlusion.
Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone. IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.
Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best medical management. | No intervention | –Best medical management consists of the standard of care of patients with acute ischemic stroke according to existing local protocols and guidelines, and may include IV thrombolysis. If treated with IVT as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO. |
| Additional intra-arterial treatment. | Experimental | Other: Intra-arterial treatmentBest medical management followed by intra-arterial treatment and best medical management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptoms and signs compatible with ischemia in the basilar artery territory.
- Basilar artery occlusion (BAO) confirmed by CTA or MRA.
- Age 18 years or older (i.e., candidates must have had their 18th birthday).
- If IVT is considered as part of best medical management, IVT should be started within 4.5 hours of estimated time of BAO. (Estimated time of BAO is defined as time of onset of acute symptoms leading to clinical diagnosis of BAO or if not known last time patient was seen normal prior to onset of these symptoms).
- Initiation of IAT should be feasible within 6 hours of estimated time of BAO.
Key exclusion criteria (11 listed)
- Pre-existing dependency with mRankin ≥3.
- Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
- Patients who require hemodialysis or peritoneal dialysis.
- Other serious, advanced, or terminal illness.
- Any other condition that the investigator feels would pose a significant hazard to the patient if thrombolytic therapy is initiated.
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 |
|---|---|---|
| Intra-arterial treatmentIA therapy has to be initiated within 6 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of IA strategy wil be made by the treating neurointerventionalist. Choice of therapy depends on local approval and experience. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a high-grade vertebral artery stenosis or occlusion hampering adequate endovascular access to the basilar artery and in case of a residual high-grade basilar artery stenosis. The use of any other treatment strategy depends on local approval and experience, and is only allowed after prior approval of the steering committee. | Other | Additional intra-arterial treatment. |
Primary outcome
Favourable outcome
Time frame: day 90
Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
4 secondary outcomes
Excellent outcome
Time frame: day 90
Modified Rankin Score
Time frame: day 90
NIHSS
Time frame: pre IVT, pre randomization, 24h post treatment
EQ-5D
Time frame: day 90 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Background: PubMed 19577962Schonewille WJ, Wijman CA, Michel P, Rueckert CM, Weimar C, Mattle HP, Engelter ST, Tanne D, Muir KW, Molina CA, Thijs V, Audebert H, Pfefferkorn T, Szabo K, Lindsberg PJ, de Freitas G, Kappelle LJ, Algra A; BASICS study group. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study. Lancet Neurol. 2009 Aug;8(8):724-30. doi: 10.1016/S1474-4422(09)70173-5. Epub 2009 Jul 3.
- Background: PubMed 22442438Greving JP, Schonewille WJ, Wijman CA, Michel P, Kappelle LJ, Algra A; BASICS Study Group. Predicting outcome after acute basilar artery occlusion based on admission characteristics. Neurology. 2012 Apr 3;78(14):1058-63. doi: 10.1212/WNL.0b013e31824e8f40. Epub 2012 Mar 21.
- Background: PubMed 22527236Vergouwen MD, Compter A, Tanne D, Engelter ST, Audebert H, Thijs V, de Freitas G, Algra A, Jaap Kappelle L, Schonewille WJ. Outcomes of basilar artery occlusion in patients aged 75 years or older in the Basilar Artery International Cooperation Study. J Neurol. 2012 Nov;259(11):2341-6. doi: 10.1007/s00415-012-6498-2. Epub 2012 Apr 18.
- Background: PubMed 21960577Puetz V, Khomenko A, Hill MD, Dzialowski I, Michel P, Weimar C, Wijman CA, Mattle HP, Engelter ST, Muir KW, Pfefferkorn T, Tanne D, Szabo K, Kappelle LJ, Algra A, von Kummer R, Demchuk AM, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Group. Extent of hypoattenuation on CT angiography source images in basilar artery occlusion: prognostic value in the Basilar Artery International Cooperation Study. Stroke. 2011 Dec;42(12):3454-9. doi: 10.1161/STROKEAHA.111.622175. Epub 2011 Sep 29.
- Background: PubMed 20947845Arnold M, Fischer U, Compter A, Gralla J, Findling O, Mattle HP, Kappelle LJ, Tanne D, Algra A, Schonewille WJ; BASICS Study Group. Acute basilar artery occlusion in the Basilar Artery International Cooperation Study: does gender matter? Stroke. 2010 Nov;41(11):2693-6. doi: 10.1161/STROKEAHA.110.594036. Epub 2010 Oct 14.
- Background: PubMed 18705948Schonewille WJ, Wijman CA, Michel P, Algra A, Kappelle LJ; BASICS Study Group. The basilar artery international cooperation study (BASICS). Int J Stroke. 2007 Aug;2(3):220-3. doi: 10.1111/j.1747-4949.2007.00145.x.
- Background: PubMed 16902170Schonewille W, Wijman C, Michel P; BASICS investigators. Treatment and clinical outcome in patients with basilar artery occlusion. Stroke. 2006 Sep;37(9):2206; author reply 2207. doi: 10.1161/01.STR.0000237127.84408.c0. Epub 2006 Aug 10. No abstract available.
- Background: PubMed 22989501Vergouwen MD, Algra A, Pfefferkorn T, Weimar C, Rueckert CM, Thijs V, Kappelle LJ, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Study Group. Time is brain(stem) in basilar artery occlusion. Stroke. 2012 Nov;43(11):3003-6. doi: 10.1161/STROKEAHA.112.666867. Epub 2012 Sep 18.
- Derived from this study: PubMed 34125952Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.
- Derived from this study: PubMed 34010530Langezaal LCM, van der Hoeven EJRJ, Mont'Alverne FJA, de Carvalho JJF, Lima FO, Dippel DWJ, van der Lugt A, Lo RTH, Boiten J, Lycklama A Nijeholt GJ, Staals J, van Zwam WH, Nederkoorn PJ, Majoie CBLM, Gerber JC, Mazighi M, Piotin M, Zini A, Vallone S, Hofmeijer J, Martins SO, Nolte CH, Szabo K, Dias FA, Abud DG, Wermer MJH, Remmers MJM, Schneider H, Rueckert CM, de Laat KF, Yoo AJ, van Doormaal PJ, van Es ACGM, Emmer BJ, Michel P, Puetz V, Audebert HJ, Pontes-Neto OM, Vos JA, Kappelle LJ, Algra A, Schonewille WJ; BASICS Study Group. Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion. N Engl J Med. 2021 May 20;384(20):1910-1920. doi: 10.1056/NEJMoa2030297.
- Derived from this study: PubMed 23835026van der Hoeven EJ, Schonewille WJ, Vos JA, Algra A, Audebert HJ, Berge E, Ciccone A, Mazighi M, Michel P, Muir KW, Obach V, Puetz V, Wijman CA, Zini A, Kappelle JL; BASICS Study Group. The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial. Trials. 2013 Jul 8;14:200. doi: 10.1186/1745-6215-14-200.
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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.
W J Schonewille, MD principal investigator
St. Antonius Hospital
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-arterial treatment in people with Basilar Artery Thrombosis and Basilar Artery Embolism, run by Erik van der Hoeven at 27 sites in 6 countries.
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 11 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Netherlands, Italy, Germany, Brazil, Norway and 1 more country. 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 Wouter Schonewille, MD (+31 6 41285149, w.schonewille@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favourable outcome (time frame: day 90). 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 NCT01717755, which also lists 11 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 18 Jan 2018.