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

• Sponsor: University Hospital Inselspital, Berne (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05499832
• Collaborator: (none)
• Enrollment: 156
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Tenecteplase	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 156 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel AssignmentParallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Jul 31, 2025
• Anticipated Study Completion Date: Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Best Medical Treatment (standard of care) Patients will receive standard of care as per current ESO guidelines.
Experimental: Intra-arterial Tenecteplase Patients will receive intra-arterial administration of Tenecteplase using a standard approved microcatheter.	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.

Outcome Measures

Primary Outcome Measures

1. Early reperfusion of the residual intracranial occlusion(s) [25 minutes after randomization]

   Defined by reperfusion improvement on angiography images

2. Late reperfusion of the residual intracranial occlusion(s) [24 hours ±6 hours]

   Defined by complete reperfusion on perfusion imaging

Secondary Outcome Measures

1. Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis) [90 days+/-15 days]

   mRS

2. Normalized change in National Institute of Health Score Scale (NIHSS) [24 hours +/- 6 hours post-randomization]

   NIHSS

3. Change in National Institute of Health Score Scale (NIHSS) [90 days +/- 15 days post-randomization]

   NIHSS

4. Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L) [90 days +/- 15 days]

   EuroQol 5D-3L

5. All-cause mortality [90 days]

   Mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsspital Bern	Bern		Switzerland	3010

Sponsors and Collaborators

• University Hospital Inselspital, Berne

Investigators

• Study Director: Urs Fischer, PhD, NCTU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT05499832
• Other Study ID Numbers: 2022-00388
• First Posted: Aug 12, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ischemic Stroke; Tenecteplase

Study Results

No Results Posted as of Aug 12, 2022