Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHui-Sheng Chen

About this trial

In 2015, five randomized trials showed efficacy of endovascular thrombectomy over standard medical care in patients with acute ischemic stroke caused by occlusion of arteries of the proximal anterior circulation. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under thrombectomy. There is a lack of evidence that whether salvage intra-arterial thrombolysis is beneficial for patients with insufficient recanalization after endovascular thrombectomy. The EXTEND-IA TNK study indicated that tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset. This study intends to explore the proportion of sufficient recanalization (2b/3) after intra-arterial tenecteplase administration in patients undergoing thrombectomy with insufficient recanalization (1/2a).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;

insufficient perfusion (mTICI 1/2a) after endovascular treatment;

The availability of informed consent.

Disqualifiers

Sufficient recanalization (TICI 2b-3);

More than 3 times of thrombectomy device passes

Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage

Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia ( <100000/mm3)

Trial design

Design model

Single group

Treatments tested in this trial

  • Intra-arterial administration of tenecteplase

    Drug

    Intra-arterial administration of tenecteplase (0.2-0.4 mg/min) immediately after thrombectomy device pass for 30-40 minutes.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Intra-arterial administration of tenecteplaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of sufficient recanalization

sufficient recanalization is defined as TICI 2b-3

Time frame
immediately after local TNK treatment

Secondary outcomes

1

Proportion of favorable outcome

favorable outcome is defined as mRS 0-2

Time frame
90 days
2

proportion of early neurological improvement

early neurological improvement is defined as more than 4 decrease in NIHSS

Time frame
48 hours

Other outcomes

1

incidence of symptomatic intracranial haemorrhage

intracranial haemorrhage is defined as more than 4 increase in NIHSS caused by intracranial bleeding

Time frame
48 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hui-Sheng Chen

Lead sponsor

General Hospital of Shenyang Military Region

Sponsor institution