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

Ischemic Stroke Clinical Trial

— TECNO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499832
• Other study ID #: 2022-00388
• Status: Recruiting
• Phase: Phase 3
• Start date: March 21, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: Urs Fischer, Prof
• Phone: +41 61 328 45 09
• Email: urs.fischer[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: October 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Universitätsspital Basel	Basel
Switzerland	Universitätsspital Bern	Bern
Switzerland	Hôpitaux universitaires de Genève	Genève
Switzerland	Ospedale Regionale di Lugano	Lugano
Switzerland	Kantonsspital St.Gallen	St.Gallen
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early reperfusion of the residual intracranial occlusion(s)	Defined by reperfusion improvement on angiography images	25 minutes after randomization
Primary	Late reperfusion of the residual intracranial occlusion(s)	Defined by complete reperfusion on perfusion imaging	24 hours ±6 hours
Secondary	Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis)	mRS	90 days+/-15 days
Secondary	Normalized change in National Institute of Health Score Scale (NIHSS)	NIHSS	24 hours +/- 6 hours post-randomization
Secondary	Change in National Institute of Health Score Scale (NIHSS)	NIHSS	90 days +/- 15 days post-randomization
Secondary	Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L)	EuroQol 5D-3L	90 days +/- 15 days
Secondary	All-cause mortality	Mortality	90 days