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

March 28, 2023 updated by: University Hospital Inselspital, Berne
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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

156

Phase

  • 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 Backup

  • Name: Seraina Martina Beyeler, PhD
  • Phone Number: +41316323970
  • Email: nctu@insel.ch

Study Locations

  • Switzerland
      • Basel, Switzerland
        • Recruiting
        • Universitatsspital Basel
        • Contact:
        • Principal Investigator:
          • Marios Psychogios, Prof
      • Bern, Switzerland, 3010
        • Recruiting
        • Universitätsspital Bern
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jan Gralla, Prof
      • Genève, Switzerland, 1211
        • Not yet recruiting
        • Hôpitaux universitaires de Genève
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emmanuel Carrera, Dr
      • Lugano, Switzerland, 6900
        • Not yet recruiting
        • Ospedale Regionale di Lugano
        • Contact:
          • Cianfoni Alessandro, Dr
        • Contact:
          • Zara Hassan
        • Principal Investigator:
          • Alessandro Cianfoni, Dr
      • St.Gallen, Switzerland, 9007
        • Not yet recruiting
        • Kantonsspital St.Gallen
        • Contact:
          • Pasquale Mordasini, Prof
        • Contact:
          • Vjosa Iljazi
        • Principal Investigator:
          • Pasquale Mordasini, Prof
      • Zürich, Switzerland, 8091

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Informed consent
  • Age ≥18 years
  • Clinical signs consistent with an acute ischemic stroke
  • Patient had an initial large vessel occlusion in the anterior circulation defined as intracranial ICA, M1 or M2.
  • Patient has undergone endovascular stroke treatment
  • Onset to randomization no later than < 345 minutes after symptom-onset/last-seen well.

  • Incomplete reperfusion defined as

    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 M2: TICI2a/2b/2c (1-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist).
    3. ICA/M1/M2 with TICI3 reperfusion (MCA territory) but emboli to the ACA 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)
  • Patients with both, anterior and middle cerebral artery embolizations during the procedure
  • Tandem occlusion requiring cervical stenting
  • Any severe bleeding within the past 6 months
  • Major surgery in the past 2 months
  • Intake of direct oral anticoagulants <12h or Vitamin K Antagonist with INR >1.3
  • Platelets < 50,000
  • Non-controlled hypertension (defined as SBP >185 mmHg or DBP >110 mmHg refractory to treatment)

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
Intervention / Treatment
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

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

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

University Hospital Inselspital, Berne

Investigators

  • Study Director: Urs Fischer, PhD, NCTU

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)

March 21, 2023

Primary Completion (Anticipated)

July 31, 2025

Study Completion (Anticipated)

October 31, 2025

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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