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Basilar Artery International Cooperation Study (BASICS)

Primary Purpose

Basilar Artery Thrombosis, Basilar Artery Embolism, Stroke of Basilar Artery

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intra-arterial treatment
Sponsored by
Erik van der Hoeven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basilar Artery Thrombosis focused on measuring basilar, stroke, mechanical, thrombolysis, intra-arterial, trombectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • 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.

Sites / Locations

  • Fortaleza General HospitalRecruiting
  • Hospital das Clinicas de Ribeirao PretoRecruiting
  • Klinikum AugsburgRecruiting
  • Berlin Charite HospitalRecruiting
  • Dresden University HospitalRecruiting
  • University Medical Center Mannheim
  • Oberschwabenklinik
  • Bergamo HospitalRecruiting
  • Genova HospitalRecruiting
  • University Hospital ModenaRecruiting
  • Santa Corona HospitalRecruiting
  • Roma Umberto I
  • Varese HospitalRecruiting
  • Rijnstate
  • Academic Hospital MaastrichtRecruiting
  • St. Elisabeth HospitalRecruiting
  • Academic Medical CenterRecruiting
  • St. Antonius HospitalRecruiting
  • MCH WesteindeRecruiting
  • University Medical Center Groningen
  • Leiden University HospitalRecruiting
  • Erasmus Medical CenterRecruiting
  • Haga HospitalRecruiting
  • Universitary Medical Center UtrechtRecruiting
  • University Hospital North NorwayRecruiting
  • St. Olavs Hospital TrondheimRecruiting
  • University Hospital of LausanneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Best medical management.

Additional intra-arterial treatment.

Arm Description

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.

Best medical management followed by intra-arterial treatment and best medical management

Outcomes

Primary Outcome Measures

Favourable outcome
Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.

Secondary Outcome Measures

Excellent outcome
Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
Modified Rankin Score
Modified Rankin Score - not dichotomized.
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.
EQ-5D
EQ-5D (quality of life) at day 90 and at 12 months.

Full Information

First Posted
October 23, 2012
Last Updated
January 16, 2018
Sponsor
Erik van der Hoeven
Collaborators
BASICS Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT01717755
Brief Title
Basilar Artery International Cooperation Study
Acronym
BASICS
Official Title
Basilar Artery International Cooperation Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erik van der Hoeven
Collaborators
BASICS Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basilar Artery Thrombosis, Basilar Artery Embolism, Stroke of Basilar Artery, Stroke, Cerebrovascular Disorders, Basilar Artery Occlusion
Keywords
basilar, stroke, mechanical, thrombolysis, intra-arterial, trombectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Best medical management.
Arm Type
No Intervention
Arm Description
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.
Arm Title
Additional intra-arterial treatment.
Arm Type
Experimental
Arm Description
Best medical management followed by intra-arterial treatment and best medical management
Intervention Type
Other
Intervention Name(s)
Intra-arterial treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Favourable outcome
Description
Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
Time Frame
day 90
Secondary Outcome Measure Information:
Title
Excellent outcome
Description
Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
Time Frame
day 90
Title
Modified Rankin Score
Description
Modified Rankin Score - not dichotomized.
Time Frame
day 90
Title
NIHSS
Description
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.
Time Frame
pre IVT, pre randomization, 24h post treatment
Title
EQ-5D
Description
EQ-5D (quality of life) at day 90 and at 12 months.
Time Frame
day 90 and 12 months
Other Pre-specified Outcome Measures:
Title
Recanalization
Description
Recanalization at 24 hours ± 6 hours, by CT angiography.
Time Frame
24 hours ± 6 hours
Title
Volume of cerebral infarction
Description
Volume of cerebral infarction on NCCT and CTA source images.
Time Frame
24 hours ± 6 hours
Title
SICH
Description
Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.
Time Frame
24 hours ± 6 hours.
Title
Mortality
Description
Mortality at 90 days.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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. Exclusion criteria 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wouter Schonewille, MD
Phone
+31 6 41285149
Email
w.schonewille@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Erik van der Hoeven, MD
Phone
+31 6 47490060
Email
e.van.der.hoeven@antoniusziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W J Schonewille, MD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fortaleza General Hospital
City
Fortaleza
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F Mont Alverne
Facility Name
Hospital das Clinicas de Ribeirao Preto
City
Ribeirão Preto
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
O Pontes Neto
Facility Name
Klinikum Augsburg
City
Augsburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hauke Schneider
Facility Name
Berlin Charite Hospital
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heinrich Audebert, MD, PhD
Facility Name
Dresden University Hospital
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Puetz, MD, PhD
Facility Name
University Medical Center Mannheim
City
Mannheim
Country
Germany
Individual Site Status
Terminated
Facility Name
Oberschwabenklinik
City
Ravensburg
Country
Germany
Individual Site Status
Terminated
Facility Name
Bergamo Hospital
City
Bergamo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Censori, MD, PhD
Facility Name
Genova Hospital
City
Genua
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Malfatto, MD, PhD
Facility Name
University Hospital Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Zini, MD, PhD
Facility Name
Santa Corona Hospital
City
Pietra Ligure
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T. Tassinari
Facility Name
Roma Umberto I
City
Rome
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Varese Hospital
City
Varese
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.L. DeLodovici, MD, PhD
Facility Name
Rijnstate
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6800 TA
Country
Netherlands
Individual Site Status
Suspended
Facility Name
Academic Hospital Maastricht
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Staals, MD, PhD
Facility Name
St. Elisabeth Hospital
City
Tilburg
State/Province
Noord Brabant
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul de Kort, MD, PhD
Facility Name
Academic Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Nederkoorn, MD, PhD
Facility Name
St. Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3430 EM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter Schonewille, MD, PhD
Facility Name
MCH Westeinde
City
The Hague
State/Province
Zuid-Holland
ZIP/Postal Code
2512 VA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jelis Boiten, MD, PhD
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Leiden University Hospital
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marieke Wermer, MD, PhD
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diederik Dippel
Facility Name
Haga Hospital
City
The Hague
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karlijn de Laat, MD, PhD
Facility Name
Universitary Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaap Kappelle, MD, PhD
Facility Name
University Hospital North Norway
City
Tromso
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stein Harald Johnsen
Facility Name
St. Olavs Hospital Trondheim
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitta Rohweder, MD, PhD
Facility Name
University Hospital of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
CH-1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrik Michel, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19577962
Citation
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.
Results Reference
background
PubMed Identifier
22442438
Citation
Greving 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.
Results Reference
background
PubMed Identifier
22527236
Citation
Vergouwen 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.
Results Reference
background
PubMed Identifier
21960577
Citation
Puetz 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.
Results Reference
background
PubMed Identifier
20947845
Citation
Arnold 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.
Results Reference
background
PubMed Identifier
18705948
Citation
Schonewille 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.
Results Reference
background
PubMed Identifier
16902170
Citation
Schonewille 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.
Results Reference
background
PubMed Identifier
22989501
Citation
Vergouwen 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.
Results Reference
background
PubMed Identifier
34125952
Citation
Roaldsen 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.
Results Reference
derived
PubMed Identifier
34010530
Citation
Langezaal 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.
Results Reference
derived
PubMed Identifier
23835026
Citation
van 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.
Results Reference
derived
Links:
URL
http://basicstrial.com
Description
Website BASICS trial

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Basilar Artery International Cooperation Study

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