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

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Tenecteplase
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Universitätsspital BaselRecruiting
  • Universitätsspital BernRecruiting
  • Hôpitaux universitaires de Genève
  • Ospedale Regionale di Lugano
  • Kantonsspital St.Gallen
  • Universitätsspital ZürichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Best Medical Treatment (standard of care)

Intra-arterial Tenecteplase

Arm Description

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

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

Outcomes

Primary Outcome Measures

Early reperfusion of the residual intracranial occlusion(s)
Defined by reperfusion improvement on angiography images
Late reperfusion of the residual intracranial occlusion(s)
Defined by complete reperfusion on perfusion imaging

Secondary Outcome Measures

Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis)
mRS
Normalized change in National Institute of Health Score Scale (NIHSS)
NIHSS
Change in National Institute of Health Score Scale (NIHSS)
NIHSS
Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L)
EuroQol 5D-3L
All-cause mortality
Mortality

Full Information

First Posted
April 26, 2022
Last Updated
March 28, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05499832
Brief Title
Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions
Acronym
TECNO
Official Title
Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Best Medical Treatment (standard of care)
Arm Type
No Intervention
Arm Description
Patients will receive standard of care as per current ESO guidelines.
Arm Title
Intra-arterial Tenecteplase
Arm Type
Experimental
Arm Description
Patients will receive intra-arterial administration of Tenecteplase using a standard approved microcatheter.
Intervention Type
Drug
Intervention Name(s)
Tenecteplase
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early reperfusion of the residual intracranial occlusion(s)
Description
Defined by reperfusion improvement on angiography images
Time Frame
25 minutes after randomization
Title
Late reperfusion of the residual intracranial occlusion(s)
Description
Defined by complete reperfusion on perfusion imaging
Time Frame
24 hours ±6 hours
Secondary Outcome Measure Information:
Title
Degree of disability or dependence assessed by the modified ranking scale (mRS) (shift analysis)
Description
mRS
Time Frame
90 days+/-15 days
Title
Normalized change in National Institute of Health Score Scale (NIHSS)
Description
NIHSS
Time Frame
24 hours +/- 6 hours post-randomization
Title
Change in National Institute of Health Score Scale (NIHSS)
Description
NIHSS
Time Frame
90 days +/- 15 days post-randomization
Title
Quality of life as assessed by the EuroQol 5D-3L (EQ-5D-3L)
Description
EuroQol 5D-3L
Time Frame
90 days +/- 15 days
Title
All-cause mortality
Description
Mortality
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 For ICA/M1: TICI2b/2c (50-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist). For M2: TICI2a/2b/2c (1-99%) reperfusion after endovascular treatment without mechanically amendable target-occlusion (as per definition by the interventionalist). 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Urs Fischer, Prof
Phone
+41 61 328 45 09
Email
urs.fischer@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Seraina Martina Beyeler, PhD
Phone
+41316323970
Email
nctu@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urs Fischer, PhD
Organizational Affiliation
NCTU
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsspital Basel
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marios Psychogios, Prof.
Email
marios.Psychogios@usb.ch
First Name & Middle Initial & Last Name & Degree
Marios Psychogios, Prof
Facility Name
Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seraina Beyeler, PhD
Phone
+41316323970
Email
seraina.beyeler@insel.ch
Email
nctu@insel.ch
First Name & Middle Initial & Last Name & Degree
Jan Gralla, Prof
Facility Name
Hôpitaux universitaires de Genève
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Carrera, Dr
Phone
+41 79 553 38 14
Email
emmanuel.carrera@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Paolo Machi, Prof
Email
paolo.machi@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Emmanuel Carrera, Dr
Facility Name
Ospedale Regionale di Lugano
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cianfoni Alessandro, Dr
First Name & Middle Initial & Last Name & Degree
Zara Hassan
First Name & Middle Initial & Last Name & Degree
Alessandro Cianfoni, Dr
Facility Name
Kantonsspital St.Gallen
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pasquale Mordasini, Prof
First Name & Middle Initial & Last Name & Degree
Vjosa Iljazi
First Name & Middle Initial & Last Name & Degree
Pasquale Mordasini, Prof
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Kulcsar, Dr
Email
zsolt.kulcsar@usz.ch
First Name & Middle Initial & Last Name & Degree
Elizabeth Rose
Email
elizabeth.rose@usz.ch
First Name & Middle Initial & Last Name & Degree
Zsolt Kulcsar, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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