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Ischemic StrokePhase 3TECNONCT05499832

Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions

A Phase 3 study testing Tenecteplase in people with Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 52 sites in 7 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

TECNO is a multicenter, prospective, randomized, open label, blinded endpoint (PROBE) proof-of-concept trial evaluating if additional administration of intra-arterial Tenecteplase (TNK) improves reperfusion in patients with incomplete mechanical thrombectomy (MT). 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?
Tenecteplase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
52 sitesin 7 countries
Study dates
21 Mar 2023to 9 Oct 2025
Phase
Phase 3
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
  • Age ≥18 years
  • Clinical signs consistent with an acute ischemic stroke
  • Patient had an initial vessel occlusion in the anterior or posterior circulation defined as intracranial ICA, M1, M2, M3, A1, A2, P1 or P2
  • Patient has undergone endovascular stroke treatment
  • Onset to randomization no later than \< 705 minutes (11h 45min) after symptom-onset/last-seen well.
Show all 11Show fewer
  • Incomplete reperfusion defined as any of the following:
  • For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).
  • For A1/A2, P1/P2, M2/M3: TICI2a/2b/2c (1-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).
  • Any emboli to new territory without mechanically amendable target-occlusion (as per definition by the interventionalist).
  • Signs of early ischemic changes of non-contrast CT Alberta Stroke Program Early CT Score (ASPECTS) ≥5 (for DWI-ASPECTS ≥ 4, for DWI-ASECTS: a region must have diffusion abnormality in 20% or more of its volume to be considered DWI-ASPECTS positive)

Who cannot join

  • Acute intracranial hemorrhage
  • Contraindication to MRI (e.g. pacemaker)
  • Any severe bleeding within the past 6 months, which would prevent administration of intravenous thrombolysis in clinical routine Major surgery in the past 2 months with severe risk of bleeding, which would prevent administration of intravenous thrombolysis in clinical routine
  • Intake of Vitamin K antagonists with INR \>1.7
  • Platelets \< 50,000
  • Non-controlled hypertension (defined as SBP \>185 mmHg or DBP \>110 mmHg refractory to treatment)
Show all 19Show fewer
  • Active dyspeptic ulcer
  • Known arterial aneurysm
  • Known neoplasms with risk of bleeding
  • Severe liver fibrosis or portal hypertension
  • Acute pericarditis
  • Acute endocarditis
  • Acute pancreatitis
  • Known allergy to TNK or Gentamicin or other additives/auxiliaries (Polysorbatum 20, L-Argininum, Acidum phosphoricum)
  • Known Renal failure either as defined by a serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] \< 30 or as subject who required hemodialysis/peritoneal dialysis
  • Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma)
  • Radiological confirmed evidence of cerebral vasculitis
  • Calcified thrombi
  • Pregnancy or lactating women

Trial locations and contacts

52 sites in 7 countries.

52 sites in 7 countries

Germany20 sites

  • Universitätsklinikum Augsburg

    Augsburg, 86156

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Klinikum Bremen-Mitte

    Bremen, 28205

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, 01307

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Universitätsklinikum Frankfurt

    Frankfurt, 60528

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Universitätsklinikum Halle (Saale)

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • Universitätsklinikum Magdeburg A. ö. R.

    Magdeburg, 39120

  • Universitätsmedizin Mannheim

    Mannheim, 68167

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Klinikum der Universität München

    München, 81377

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Universitätsklinikum Münster

    Münster, 48149

  • Städtisches Klinikum Sollingen

    Solingen, 42653

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

Switzerland13 sites

  • Kantonsspital Aarau AG

    Aarau, 5001

  • Kantonsspital Aarau

    Aarau, 5001

  • Kantonsspital Aarau

    Aarau

  • Universitätsspital Basel

    Basel

  • Universitätsspital Bern

    Bern, 3010

  • Hôpitaux universitaires de Genève

    Geneva, 1211

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • University Hospital of Lausanne

    Lausanne

  • Kantonsspital Luzern

    Lucerne, 6000

  • Ospedale Regionale di Lugano

    Lugano, 6900

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Belgium7 sites

  • Hôpital universitaires de Bruxelles

    Anderlecht, 1070

  • AZ Sint Jan Brugge AV

    Bruges, 8000

  • UZ Brussel

    Brussels, 1050

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Gasthuisberg Leuven

    Leuven, 3000

  • Clinique CHC MontLégia

    Liège, 4000

Other trials in Belgium

Portugal5 sites

  • Hospital de Braga

    Braga, 4710-243

  • Hospital Nelio Mendonca Funchal

    Funchal, 9000-177

  • Lisbon Central University Hospital

    Lisbon, 1150-199

  • Hospital Eagas Moniz

    Lisbon, 1349-019

  • Hospital Santo Antonio

    Porto, 4099-001

Other trials in Portugal

Austria4 sites

  • LKH-Universitätsklinikum Graz

    Graz, 8036

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Kepler Universitätsklinikum GmbH

    Linz, 4020

  • Christian-Doppler-Klinik Salzburg

    Salzburg, 5020

Other trials in Austria

Netherlands2 sites

  • Amsterdam UMC

    Amsterdam, 1100

  • Leiden UMC

    Leiden, 2300

Other trials in Netherlands

Finland1 site

  • University Hospital Helsinki

    Helsinki, 00029

Other trials in Finland

About this study

TECNO is a multicenter, prospective, randomized, open label, blinded endpoint (PROBE) proof-of-concept trial evaluating if additional administration of intra-arterial Tenecteplase (TNK) improves reperfusion in patients with incomplete mechanical thrombectomy (MT). For this purpose, 156 adult participants experiencing an acute ischemic stroke due to a large vessel occlusion with incomplete reperfusion with residual occlusions after MT will be randomly assigned to receive 3mg intra-arterial (IA) TNK or best medical treatment. Recruitment will occur at 20 academic tertiary stroke care centers in Switzerland, Spain, Belgium, and Germany and patients are followed up for 90 days after the index event. Showing superiority for reperfusion outcomes would have a major impact on the future management of stroke patients.

Conditions
Ischemic Stroke
Being tested
Tenecteplase
Medical subject headings
Ischemic Stroke

What participants receive

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

  • TenecteplaseDrug

    Patients randomized to IA treatment will receive IA TNK via a standard approved microcatheter positioned as close as possible to the residual occlusion site or as distal as possible in the originating vessel if multiple residual occlusions exists.

Study groups in NCT05499832
Study groupRoleWhat they receive
Best Medical Treatment (standard of care)No interventionPatients will receive standard of care as per current ESO guidelines.
Intra-arterial TenecteplaseExperimentalPatients will receive intra-arterial administration of Tenecteplase using a standard approved microcatheter.
Receives: Drug: Tenecteplase

What is being measured

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

  1. Early reperfusion of the residual intracranial occlusion(s)

    Defined by reperfusion improvement on angiography images

    Measured: 25 minutes after randomization

  2. Late reperfusion of the residual intracranial occlusion(s)

    Defined by complete reperfusion on perfusion imaging

    Measured: 24 hours ±6 hours

Secondary outcomes (5)

  1. Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis)

    mRS

    Measured: 90 days+/-15 days

  2. Normalized change in National Institute of Health Score Scale (NIHSS)

    NIHSS

    Measured: 24 hours +/- 6 hours post-randomization

  3. Change in National Institute of Health Score Scale (NIHSS)

    NIHSS

    Measured: 90 days +/- 15 days post-randomization

  4. Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L)

    EuroQol 5D-3L

    Measured: 90 days +/- 15 days

  5. All-cause mortality

    Mortality

    Measured: 90 days

Timeline

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

  1. First posted12 Aug 2022
  2. Study start21 Mar 2023
  3. Primary completion9 Oct 2025
  4. Study completion9 Oct 2025

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05499832
Sponsor's protocol ID
2022-00388
Acronym
TECNO
Status last verified
Feb 2026
First submitted
26 Apr 2022
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mujanovic A, Windecker D, Cimflova P, Meinel TR, Seiffge DJ, Auer E, Boulouis G, Arnold M, Serrallach BL, Rohner R, Janot K, Dobrocky T, Hill MD, Goyal M, Piechowiak EI, Gralla J, Fischer U, Kaesmacher J. Natural Evolution of Incomplete Reperfusion in Patients Following Endovascular Therapy After Ischemic Stroke. Stroke. 2025 Feb;56(2):447-455. doi: 10.1161/STROKEAHA.124.049641. Epub 2024 Nov 20.

    PubMed 39567366

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenecteplase in people with Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 52 sites in 7 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 11 inclusion and 19 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Germany, Switzerland, Belgium, Portugal, Austria and 2 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Early reperfusion of the residual intracranial occlusion(s) (time frame: 25 minutes after randomization). The study lists 2 primary outcomes in all. 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 NCT05499832, which also lists 1 linked publication.

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 10 Feb 2026.

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