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Using Tenecteplase to improve blood flow in stroke patients after thrombectomy

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

Phase 3 Interventional Insel Gruppe AG, University Hospital Bern · NCT05499832

This study is testing if a new treatment called Tenecteplase can help improve blood flow in stroke patients who have had a procedure to remove a blockage but still need better recovery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment156 (estimated)
Ages18 Years and up
SexAll
SponsorInsel Gruppe AG, University Hospital Bern Academic / other
Locations38 sites (Graz and 37 other locations)
Trial IDNCT05499832 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and efficacy of administering intra-arterial Tenecteplase (TNK) to patients who have experienced an acute ischemic stroke and have undergone mechanical thrombectomy but still show incomplete reperfusion. A total of 156 adult participants will be randomly assigned to receive either TNK or the best medical treatment available. The study aims to determine if TNK can enhance reperfusion outcomes in these patients, with follow-up assessments conducted over 90 days. The trial is being conducted across 20 academic tertiary stroke care centers in Switzerland, Spain, Belgium, and Germany.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute ischemic stroke with incomplete reperfusion after mechanical thrombectomy.

Not a fit: Patients who have complete reperfusion or those with contraindications to Tenecteplase may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood flow restoration in stroke patients, potentially leading to better recovery outcomes.

How similar studies have performed: Previous studies have shown promising results with similar thrombolytic approaches, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Graz and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic Stroke
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.