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

February 5, 2026 updated by: Insel Gruppe AG, University Hospital Bern
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Seraina Martina Beyeler, PhD
  • Phone Number: +41316323970
  • Email: nctu@insel.ch

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria, 8036
        • LKH-Universitätsklinikum Graz
      • Innsbruck, Austria, 6020
        • Medizinische Universität Innsbruck
      • Linz, Austria, 4020
        • Kepler Universitätsklinikum GmbH
      • Salzburg, Austria, 5020
        • Christian-Doppler-Klinik Salzburg
  • Belgium
      • Anderlecht, Belgium, 1070
        • Hôpital universitaires de Bruxelles
      • Bruges, Belgium, 8000
        • AZ Sint Jan Brugge AV
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
      • Brussels, Belgium, 1050
        • UZ Brussel
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg Leuven
      • Liège, Belgium, 4000
        • Clinique CHC MontLégia
  • Finland
      • Helsinki, Finland, 00029
        • University Hospital Helsinki
  • Germany
      • Augsburg, Germany, 86156
        • Universitätsklinikum Augsburg
      • Bonn, Germany, 53127
        • Universitatsklinikum Bonn
      • Bremen, Germany, 28205
        • Klinikum Bremen-Mitte
      • Dresden, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt
      • Frankfurt, Germany, 60528
        • Universitätsklinikum Frankfurt
      • Freiburg im Breisgau, Germany, 79106
        • Universitatsklinikum Freiburg
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen
      • Halle, Germany, 06120
        • Universitätsklinikum Halle (Saale)
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg A. ö. R.
      • Mannheim, Germany, 68167
        • Universitätsmedizin Mannheim
      • Minden, Germany, 32429
        • Johannes Wesling Klinikum Minden
      • München, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universität München
      • München, Germany, 81377
        • Klinikum der Universität München
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Solingen, Germany, 42653
        • Städtisches Klinikum Sollingen
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen
  • Netherlands
      • Amsterdam, Netherlands, 1100
        • Amsterdam UMC
      • Leiden, Netherlands, 2300
        • Leiden UMC
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Funchal, Portugal, 9000-177
        • Hospital Nelio Mendonca Funchal
      • Lisbon, Portugal, 1150-199
        • Lisbon Central University Hospital
      • Lisbon, Portugal, 1349-019
        • Hospital Eagas Moniz
      • Porto, Portugal, 4099-001
        • Hospital Santo Antonio
  • Switzerland
      • Aarau, Switzerland
        • Kantonsspital Aarau
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau AG
      • Basel, Switzerland
        • Universitätsspital Basel
      • Bern, Switzerland, 3010
        • Universitätsspital Bern
      • Geneva, Switzerland, 1211
        • Hopitaux Universitaires de Geneve
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Lausanne, Switzerland
        • University Hospital of Lausanne
      • Lucerne, Switzerland, 6000
        • Kantonsspital Luzern
      • Lugano, Switzerland, 6900
        • Ospedale Regionale di Lugano
      • Sankt Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen
      • Zurich, Switzerland, 8091
        • Universitätsspital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.

  • Incomplete reperfusion defined as any of the following:

    1. For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).
    2. 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).
    3. 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)

Exclusion Criteria

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Best Medical Treatment (standard of care)
Patients will receive standard of care as per current ESO guidelines.
Experimental: Intra-arterial Tenecteplase
Patients will receive intra-arterial administration of Tenecteplase using a standard approved microcatheter.
Drug: Tenecteplase
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early reperfusion of the residual intracranial occlusion(s)
Time Frame: 25 minutes after randomization
Defined by reperfusion improvement on angiography images
25 minutes after randomization
Late reperfusion of the residual intracranial occlusion(s)
Time Frame: 24 hours ±6 hours
Defined by complete reperfusion on perfusion imaging
24 hours ±6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis)
Time Frame: 90 days+/-15 days
mRS
90 days+/-15 days
Normalized change in National Institute of Health Score Scale (NIHSS)
Time Frame: 24 hours +/- 6 hours post-randomization
NIHSS
24 hours +/- 6 hours post-randomization
Change in National Institute of Health Score Scale (NIHSS)
Time Frame: 90 days +/- 15 days post-randomization
NIHSS
90 days +/- 15 days post-randomization
Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L)
Time Frame: 90 days +/- 15 days
EuroQol 5D-3L
90 days +/- 15 days
All-cause mortality
Time Frame: 90 days
Mortality
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Urs Fischer, PhD, NCTU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-00388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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