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

Phase 3

Recruiting

• Conditions: Ischemic Stroke
• Interventions: Drug: Tenecteplase

• Registration Number: NCT05499832
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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). 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Study Start: 2023-03-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-arterial Tenecteplase	Tenecteplase	Patients will receive intra-arterial administration of Tenecteplase using a standard approved microcatheter.

Primary Outcome Measures

Name	Time	Method
Early reperfusion of the residual intracranial occlusion(s)	25 minutes after randomization	Defined by reperfusion improvement on angiography images
Late reperfusion of the residual intracranial occlusion(s)	24 hours ±6 hours	Defined by complete reperfusion on perfusion imaging

Secondary Outcome Measures

Name	Time	Method
Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis)	90 days+/-15 days	mRS
Normalized change in National Institute of Health Score Scale (NIHSS)	24 hours +/- 6 hours post-randomization	NIHSS
Change in National Institute of Health Score Scale (NIHSS)	90 days +/- 15 days post-randomization	NIHSS
Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L)	90 days +/- 15 days	EuroQol 5D-3L
All-cause mortality	90 days	Mortality

Trial Locations

Locations (38)

LKH-Universitätsklinikum Graz; 🇦🇹 Graz, Austria

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria

Kepler Universitätsklinikum GmbH; 🇦🇹 Linz, Austria

Christian-Doppler-Klinik Salzburg; 🇦🇹 Salzburg, Austria

Hôpital universitaires de Bruxelles; 🇧🇪 Anderlecht, Belgium

AZ Sint Jan Brugge AV; 🇧🇪 Brugge, Belgium

UZ Brussel; 🇧🇪 Brussel, Belgium

Cliniques universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

UZ Gasthuisberg Leuven; 🇧🇪 Leuven, Belgium

Clinique CHC MontLégia; 🇧🇪 Liège, Belgium

University Hospital Helsinki; 🇫🇮 Helsinki, Finland

Universitätsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Klinikum Bremen-Mitte; 🇩🇪 Bremen, Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden; 🇩🇪 Dresden, Germany

Helios Klinikum Erfurt; 🇩🇪 Erfurt, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum Halle (Saale); 🇩🇪 Halle, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Germany

Universitätsklinikum Magdeburg A. ö. R.; 🇩🇪 Magdeburg, Germany

Universitätsmedizin Mannheim; 🇩🇪 Mannheim, Germany

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

Klinikum der Universität München; 🇩🇪 München, Germany

Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 München, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Hôpitaux universitaires de Genève; 🇨🇭 Genève, Switzerland

Ospedale Regionale di Lugano; 🇨🇭 Lugano, Switzerland

Kantonsspital Luzern; 🇨🇭 Luzern, Switzerland

Kantonsspital St.Gallen; 🇨🇭 St.Gallen, Switzerland

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland