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

NCT05499832 | Completed Phase 3 DMC

• 1 other identifier: 2022-00388
• Study Type: interventional
• Target: 156
• Locations: 7 countries
• Sites: 52

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

Outcome Measures

Primary Outcomes (2)

• Early reperfusion of the residual intracranial occlusion(s)

  Defined by reperfusion improvement on angiography images

  25 minutes after randomization

• Late reperfusion of the residual intracranial occlusion(s)

  Defined by complete reperfusion on perfusion imaging

  24 hours ±6 hours

Secondary Outcomes (5)

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

  90 days+/-15 days

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

  24 hours +/- 6 hours post-randomization

• Change in National Institute of Health Score Scale (NIHSS)

  90 days +/- 15 days post-randomization

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

  90 days +/- 15 days

• All-cause mortality

  90 days

Study Arms (2)

Best Medical Treatment (standard of care)

NO INTERVENTION

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

Intra-arterial Tenecteplase

EXPERIMENTAL

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

Drug: Tenecteplase

Interventions

Tenecteplase 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.

Intra-arterial Tenecteplase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (52)

LKH-Universitätsklinikum Graz

Graz, 8036, Austria

Location

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Kepler Universitätsklinikum GmbH

Linz, 4020, Austria

Location

Christian-Doppler-Klinik Salzburg

Salzburg, 5020, Austria

Location

Hôpital universitaires de Bruxelles

Anderlecht, 1070, Belgium

Location

AZ Sint Jan Brugge AV

Bruges, 8000, Belgium

Location

UZ Brussel

Brussels, 1050, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Gasthuisberg Leuven

Leuven, 3000, Belgium

Location

Clinique CHC MontLégia

Liège, 4000, Belgium

Location

University Hospital Helsinki

Helsinki, 00029, Finland

Location

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Klinikum Bremen-Mitte

Bremen, 28205, Germany

Location

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Helios Klinikum Erfurt

Erfurt, 99089, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60528, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Universitätsklinikum Magdeburg A. ö. R.

Magdeburg, 39120, Germany

Location

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

Location

Johannes Wesling Klinikum Minden

Minden, 32429, Germany

Location

Klinikum der Universität München

München, 81377, Germany

Location

Klinikum rechts der Isar der Technischen Universität München

München, 81675, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Städtisches Klinikum Sollingen

Solingen, 42653, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Amsterdam UMC

Amsterdam, 1100, Netherlands

Location

Leiden UMC

Leiden, 2300, Netherlands

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Hospital Nelio Mendonca Funchal

Funchal, 9000-177, Portugal

Location

Lisbon Central University Hospital

Lisbon, 1150-199, Portugal

Location

Hospital Eagas Moniz

Lisbon, 1349-019, Portugal

Location

Hospital Santo Antonio

Porto, 4099-001, Portugal

Location

Kantonsspital Aarau AG

Aarau, 5001, Switzerland

Location

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Kantonsspital Aarau

Aarau, Switzerland

Location

Universitätsspital Basel

Basel, Switzerland

Location

Universitätsspital Bern

Bern, 3010, Switzerland

Location

Hôpitaux universitaires de Genève

Geneva, 1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

University Hospital of Lausanne

Lausanne, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, 6900, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39567366 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Urs Fischer, PhD

  NCTU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: August 12, 2022
• Study Start: March 21, 2023
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); PT (5); CH (13); BE (7); FI (1); AU (4); DE (20)