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

NCT ID: NCT05499832

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2026-12-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Best Medical Treatment (standard of care)

Patients will receive standard of care as per current ESO guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intra-arterial Tenecteplase

Patients will receive intra-arterial administration of Tenecteplase using a standard approved microcatheter.

Group Type: EXPERIMENTAL

Tenecteplase

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urs Fischer, PhD

Role: STUDY_DIRECTOR

NCTU

Locations

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

Bruges, , Belgium

UZ Brussel

Brussels, , Belgium

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , 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 im Breisgau, , 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

Städtisches Klinikum Sollingen

Solingen, , Germany

Universitätsklinikum Tübingen

Tübingen, , Germany

Amsterdam UMC

Amsterdam, , Netherlands

Leiden UMC

Leiden, , Netherlands

Hospital de Braga

Braga, , Portugal

Hospital Nelio Mendonca Funchal

Funchal, , Portugal

Lisbon Central University Hospital

Lisbon, , Portugal

Hospital Eagas Moniz

Lisbon, , Portugal

Hospital Santo Antonio

Porto, , Portugal

Kantonsspital Aarau AG

Aarau, , Switzerland

Kantonsspital Aarau

Aarau, , Switzerland

Kantonsspital Aarau

Aarau, , Switzerland

Universitätsspital Basel

Basel, , Switzerland

Universitätsspital Bern

Bern, , Switzerland

Hôpitaux universitaires de Genève

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

University Hospital of Lausanne

Lausanne, , Switzerland

Kantonsspital Luzern

Lucerne, , Switzerland

Ospedale Regionale di Lugano

Lugano, , Switzerland

Kantonsspital St.Gallen

Sankt Gallen, , Switzerland

Universitätsspital Zürich

Zurich, , Switzerland

Countries

Austria; Belgium; Finland; Germany; Netherlands; Portugal; Switzerland

References

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.

Reference Type: DERIVED

PMID: 39567366 (View on PubMed)

Other Identifiers

2022-00388

Identifier Type: -

Identifier Source: org_study_id