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Ischemic StrokeSWIFT DIRECTNCT03192332

Bridging Thrombolysis Versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke

A study testing Stent-retriever thrombectomy with revascularization device of the Solitaire™ type and Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) in people with Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 48 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal vessel occlusion in the anterior circulation… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Stent-retriever thrombectomy with revascularization device of the Solitaire™ type and Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
48 sitesin 8 countries
Study dates
29 Nov 2017to 11 Aug 2021
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

  • Informed consent as documented by signature
  • Age ≥ 18
  • Clinical signs consistent with an acute ischemic stroke
  • Neurological deficit with a NIHSS of ≥ 5 and < 30 (deficits judged to be clearly disabling at presentation)
  • Patient is eligible for intravenous thrombolysis
  • Patient is eligible for endovascular treatment
Show all 9Show fewer
  • Randomization no later than 4 hours 15 minutes after stroke symptom onset and initiation of IV t-PA must be started within 4 hours 30 minutes of stroke symptoms onset (onset time is measured from the time when the subject was last seen well)
  • Occlusion (TICI 0-1) of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography, accessible for MT
  • Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) greater than or equal to 4 (≥ 4) based on baseline CT or MR imaging (MRI) (a region has to have diffusion abnormality in 20% or more of its volume to be considered MR-ASPECTS positive)

Who cannot join

  • Acute intracranial hemorrhage
  • Any contraindication for IV t-PA
  • Pre-treatment with IV t-PA
  • In-hospital stroke
  • Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential.
  • Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals, or their alloys
Show all 18Show fewer
  • Known current participation in a clinical trial (investigational drug or medical device)
  • Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) or glomerular filtration rate (GFR) < 30 mL/min or requirement for hemodialysis or peritoneal dialysis
  • Severe comorbid condition with life expectancy less than 90 days at baseline
  • Known advanced dementia or significant pre-stroke disability (mRS score of ≥2)
  • Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
  • Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
  • Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
  • Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the femoral access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after MT
  • Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
  • Radiological confirmed evidence of cerebral vasculitis
  • CTA or MRA evidence of carotid artery dissection
  • Evidence of additional distal intracranial vessel occlusion in another territory (i.e. A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRI or CTA/MRA

Trial locations and contacts

48 sites in 8 countries.

48 sites in 8 countries

France19 sites

  • CHU de Bordeaux

    Bordeaux, 33404

  • Hôpital Cavale Blanche CHU Brest

    Brest, Finistère, 29200

  • CHU de Caen Normandie

    Caen, 14033

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, Puy-de-Dôme, 63000

  • CHU de Lille

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • Hospices Civils de Lyon

    Lyon, 69002

  • CHU de Montpellier

    Montpellier

  • CHRU Nancy

    Nancy, 54035

  • CHU de Nantes

    Nantes, 44093

  • Hôpital Bicêtre

    Paris, 75010

  • GHU Paris Psychiatrie et Neurosciences, Sainte Anne

    Paris, 75014

  • Fondation Ophtalmologique A. de Rothschild

    Paris, 75019

  • CHU de Reims

    Reims, Marne, 51100

  • CHU Rouen Normandie

    Rouen, 76031

  • CHRU Strasbourg

    Strasbourg, 67091

  • Hôpital Foch

    Suresnes, Île-de-France Region, 92150

  • CHU de Toulouse

    Toulouse, 31059

  • CHU Tours

    Tours, 37044

Other trials in France

Germany10 sites

  • Universitätsklinikum RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Universitätsklinikum Knappschaftskrankenhaus GmbH Bochum

    Bochum

  • Universitätsklinikum Frankfurt

    Frankfurt, 60528

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg

    Magdeburg

  • Universitätsmedizin Mannheim, Universität Heidelber

    Mannheim, Baden-Wurttemberg, 68167

  • Klinikum rechts der Isar der Technischen Universität München

    München

  • Klinikum Osnabrück GmbH

    Osnabrück, Lower Saxony, 49076

  • Klinikum Vest GmbH

    Recklinghausen

Other trials in Germany

Switzerland7 sites

  • Dept. of Neurology, Kantonsspital Aarau

    Aarau, Canton of Aargau, 5001

  • Dept. of Neurology, Bern University Hospital

    Bern, 3010

  • Hôpitaux Universitaires de Genève - HUG

    Geneva, 1211

  • Dept. of Neurology, Centre hospitalier universitaire vaudois (CHUV)

    Lausanne, Canton of Vaud, 1011

  • Dept. of Neurology, Ospedale Civo of Lugano

    Lugano, Canton Ticino, 6900

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

  • Dept. of Neuroradiology, UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

Canada4 sites

  • University of Calgary, Alberta Health Services

    Calgary

  • Mc Gill University

    Montreal

  • Royal University Hospital, University of Saskatchewan

    Saskatoon

  • Toronto Western Hospital

    Toronto

Other trials in Canada

United Kingdom3 sites

  • Belfast City Hospital

    Belfast

  • St George's University Hospitals NHS Foundation Trust

    London

  • Salford Royal

    Salford

Other trials in United Kingdom

Austria2 sites

  • Medical University of Innsbruck

    Innsbruck, 6020

  • Keppler Universitätsklinikum

    Linz, Upper Austria, 4020

Other trials in Austria

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

Other trials in Spain

Finland1 site

  • Helsinki University Hospital

    Helsinki, 00290

Other trials in Finland

About this study

Official title: Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke

Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal vessel occlusion in the anterior circulation has currently become a matter of debate and is a relevant unanswered question in clinical practice.

The main objective is to determine whether subjects experiencing an AIS due to large intracranial vessel occlusion in the anterior circulation will have non-inferior functional outcome at 90 days when treated with direct mechanical thrombectomy (MT) compared to subjects treated with combined IV t-PA and MT.

The secondary objectives are to study causes of mortality, dependency and quality of life in these AIS patients.

Read the detailed description

Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Since December 2014 a new era in acute stroke treatment has begun: randomized controlled studies have consistently shown that endovascular clot retrieval in addition to best medical treatment (± IV t-PA) improves outcome in acute anterior circulation stroke patients with proximal vessel occlusion compared to best medical treatment alone. Whether pre-treatment with IV t-PA prior to endovascular clot retrieval is beneficial has now become a matter of debate. A pooled analysis of 5 RCTs (MR CLEAN, SWIFT-PRIME, EXTEND IA, ESCAPE and REVASCAT) suggested that the treatment effect size of MT does not differ between patients receiving intravenous thrombolysis (IVT) and those treated with MT alone (p interaction: 0.4311). Besides post-hoc RCT analyses, there are a myriad of observational studies reporting on rates of successful reperfusion and functional outcome stratified according to IV t-PA pretreatment status. There is evidence that reperfusion rates after IV t-PA in patients with occlusions of the internal carotid artery and the main stem of the middle cerebral artery are low, but may reach more than 80% after mechanical thrombectomy (MT). Therefore the most important factor for vessel recanalization, which is linked with favorable outcome, is MT.

No randomized controlled trial has ever assessed whether direct MT in patients with AIS is equally effective as MT in combination with IV t-PA (bridging thrombolysis). In a patient-level pooled analysis of five randomized controlled studies (HERMES collaboration) similar rates of functional independence and mortality at 90 days were observed between patients who received IV t-PA+MT and those who received direct MT. However, patients in the direct MT group had contraindications for IV t-PA. Two larger studies based on registries compared the outcome of patients after bridging thrombolysis with direct MT in patients eligible for IV t-PA. In both studies, the outcome of patients after bridging thrombolysis and direct MT was similar. For these reasons the investigators hypothesize that immediate and direct MT is not inferior and might even be superior to bridging thrombolysis in patients directly referred to a stroke center with rapid access to endovascular procedures.

In this trial all commercially available stent-retriever revascularization devices manufactured by Medtronic (e.g. Solitaire™) will be used as tool for direct MT. The investigators aim to provide conclusive information on the efficacy and safety of direct MT, in comparison with bridging thrombolysis.

If direct MT in patients with AIS would not be inferior to bridging thrombolysis, the organization of acute stroke management would change essentially. Direct MT would then be the therapy of choice in stroke centers with endovascular facilities. Furthermore, this trial could have an impact on healthcare guidelines and costs. However, this trial does not address the question, whether patients arriving in stroke units with no endovascular facilities should be pre-treated with IV t-PA or whether they should directly be referred to stroke centers with endovascular facilities.

Conditions
Ischemic Stroke
Being tested
Stent-retriever thrombectomy with revascularization device of the Solitaire™ type, Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA)
Keywords
Intravenous thrombolysis, Endovascular treatment, Mechanical thrombectomy, Bridging thrombolysis, Acute ischemic stroke
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stent-retriever thrombectomy with revascularization device of the Solitaire™ typeDevice

    Mechanical thrombectomy with a stent-retriever revascularization device

  • Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA)Drug

    Bridging thrombolysis (IV t-PA plus mechanical thrombectomy) according to current European and North American stroke guidelines.

Study groups in NCT03192332
Study groupRoleWhat they receive
Direct mechanical thrombectomyExperimentalTreatment with direct mechanical thrombectomy with a commercially available stent-retriever revascularization device of the Solitaire™ type.
Receives: Device: Stent-retriever thrombectomy with revascularization device of the Solitaire™ type
Combined intravenous thrombolysis and mechanical thrombectomyActive comparatorTreatment with intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) followed by mechanical thrombectomy with a commercially available stent-retriever revascularization device of the Solitaire™ type.
Receives: Device: Stent-retriever thrombectomy with revascularization device of the Solitaire™ type; Drug: Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score in modified Rankin Scale (mRS)

    Measured: 90 days after randomization

Secondary outcomes (8)

  1. Mortality

    Measured: 90 days after randomization

  2. Modified Rankin Scale (mRS) shift analysis

    Measured: day 0 and 90 days after randomization

  3. National Institute of Health Score Scale (NIHSS)

    Measured: day 0 and day 1 after randomization

  4. Thrombolysis in Cerebral Infarction (TICI) scale

    Measured: day 0 and day 1 after randomization

  5. Serious adverse events

    Measured: day 0 until 90 days after randomization

  6. Intracranial hemorrhage

    Measured: day 1 after randomization

  7. Quality of life assessed by questionnaire

    Measured: 90 days after randomization

  8. Overall costs incurred during hospitalisation

    Measured: 90 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2017
  2. Study start29 Nov 2017
  3. Primary completion14 May 2021
  4. Study completion11 Aug 2021

Resources

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
Prospective, randomized, open label, blinded endpoint (PROBE)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03192332
Sponsor's protocol ID
2017-00974
Other IDs
2017
Acronym
SWIFT DIRECT
Status last verified
Nov 2024
First submitted
12 Jun 2017
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fladt J, Kaesmacher J, Meinel TR, Butikofer L, Strbian D, Eker OF, Albucher JF, Desal H, Marnat G, Papagiannaki C, Richard S, Requena M, Lapergue B, Pagano P, Ernst M, Wiesmann M, Boulanger M, Liebeskind DS, Gralla J, Fischer U. MRI vs CT for Baseline Imaging Evaluation in Acute Large Artery Ischemic Stroke: A Subanalysis of the SWIFT-DIRECT Trial. Neurology. 2024 Jan 23;102(2):e207922. doi: 10.1212/WNL.0000000000207922. Epub 2023 Dec 14.

    PubMed 38165324

  • Mujanovic A, Eker O, Marnat G, Strbian D, Ijas P, Preterre C, Triquenot A, Albucher JF, Gauberti M, Weisenburger-Lile D, Ernst M, Nikoubashman O, Mpotsaris A, Gory B, Tuan Hua V, Ribo M, Liebeskind DS, Dobrocky T, Meinel TR, Buetikofer L, Gralla J, Fischer U, Kaesmacher J; SWIFT DIRECT investigators. Association of intravenous thrombolysis and pre-interventional reperfusion: a post hoc analysis of the SWIFT DIRECT trial. J Neurointerv Surg. 2023 Nov;15(e2):e232-e239. doi: 10.1136/jnis-2022-019585. Epub 2022 Nov 17.

    PubMed 36396433

  • Meinel TR, Kaesmacher J, Buetikofer L, Strbian D, Eker OF, Cognard C, Mordasini P, Deppeler S, Mendes Pereira V, Albucher JF, Darcourt J, Bourcier R, Guillon B, Papagiannaki C, Costentin G, Sibolt G, Raty S, Gory B, Richard S, Liman J, Ernst M, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Weisenburger D, Requena M, Garcia-Tornel A, Saleme S, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Boix M, Pop R, Della Schiava L, Luft A, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui A, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati L, Bassetti C, Escalard S, Liebeskind D, Saver JL, Fischer U, Gralla J; SWIFT-DIRECT investigators. Time to treatment with bridging intravenous alteplase before endovascular treatment:subanalysis of the randomized controlled SWIFT-DIRECT trial. J Neurointerv Surg. 2023 Sep;15(e1):e102-e110. doi: 10.1136/jnis-2022-019207. Epub 2022 Jul 28.

    PubMed 35902234

  • Fischer U, Kaesmacher J, Strbian D, Eker O, Cognard C, Plattner PS, Butikofer L, Mordasini P, Deppeler S, Pereira VM, Albucher JF, Darcourt J, Bourcier R, Benoit G, Papagiannaki C, Ozkul-Wermester O, Sibolt G, Tiainen M, Gory B, Richard S, Liman J, Ernst MS, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Lapergue B, Ribo M, Tomasello A, Saleme S, Macian F, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Hernandez-Perez M, Pop R, Schiava LD, Luft AR, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati LH, Bassetti CL, Mazighi M, Liebeskind DS, Saver JL, Gralla J; SWIFT DIRECT Collaborators. Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial. Lancet. 2022 Jul 9;400(10346):104-115. doi: 10.1016/S0140-6736(22)00537-2.

    PubMed 35810756

  • Fischer U, Kaesmacher J, S Plattner P, Butikofer L, Mordasini P, Deppeler S, Cognard C, Pereira VM, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Strbian D, Wiesmann M, Bressan J, Lerch S, Liebeskind DS, Saver JL, Gralla J; SWIFT DIRECT study investigators. SWIFT DIRECT: Solitaire With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke: Methodology of a randomized, controlled, multicentre study. Int J Stroke. 2022 Jul;17(6):698-705. doi: 10.1177/17474930211048768. Epub 2021 Oct 14.

    PubMed 34569878

Questions about this trial

What is this clinical trial studying?

A study testing Stent-retriever thrombectomy with revascularization device of the Solitaire™ type and Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) in people with Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 48 sites in 8 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in France, Germany, Switzerland, Canada, United Kingdom and 3 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score in modified Rankin Scale (mRS) (time frame: 90 days after randomization). 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 NCT03192332, which also lists 5 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 14 Nov 2024.

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SWIFT DIRECT Clinical Trial NCT03192332 | AzTrials