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

• Sponsor: Hui-Sheng Chen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04201964
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Intra-arterial administration of tenecteplase	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK): a Prospective, Single Arm, Pilot Study
• Actual Study Start Date: Dec 15, 2019
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intra-arterial administration of tenecteplase Intra-arterial administration of tenecteplase (0.2-0.4 mg/min) immediately after thrombectomy device pass for 30-40 minutes.	Drug: Intra-arterial administration of tenecteplase; Intra-arterial administration of tenecteplase (0.2-0.4 mg/min) immediately after thrombectomy device pass for 30-40 minutes.

Outcome Measures

Primary Outcome Measures

1. Proportion of sufficient recanalization [immediately after local TNK treatment]

   sufficient recanalization is defined as TICI 2b-3

Secondary Outcome Measures

1. Proportion of favorable outcome [90 days]

   favorable outcome is defined as mRS 0-2

2. proportion of early neurological improvement [48 hours]

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

Other Outcome Measures

1. incidence of symptomatic intracranial haemorrhage [48 hours]

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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Age ≥18 years;

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

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

4. The availability of informed consent.

Exclusion Criteria:

1. Sufficient recanalization (TICI 2b-3);

2. More than 3 times of thrombectomy device passes

3. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage

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

5. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis

6. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg)

7. Patients allergic to any ingredient of drugs in our study

8. Unsuitable for this clinical studies assessed by researcher

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of Northern Theater Command	ShenYang		China	110840

Sponsors and Collaborators

• Hui-Sheng Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hui-Sheng Chen, Professor, General Hospital of Shenyang Military Region
• ClinicalTrials.gov Identifier: NCT04201964
• Other Study ID Numbers: k(2019)30
• First Posted: Dec 17, 2019
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Tenecteplase

Study Results

No Results Posted as of May 25, 2022