Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK)

NCT04202458 | Completed DMC

• 1 other identifier: k(2019)29
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under 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 whether a combination of thrombectomy and intra-arterial TNK administration can increase recanalization rate after the first attempt of thrombectomy device pass for ischemic Stroke.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of sufficient recanalization

  sufficient recanalization is defined as TICI 2b-3

  Immediately after TNK treatment

Secondary Outcomes (2)

• Proportion of favorable outcome

  90 days

• proportion of early neurological improvement

  48 hours

Other Outcomes (1)

• incidence of symptomatic intracranial haemorrhage

  48 hours

Study Arms (1)

intra-arterial tenecteplase administration

EXPERIMENTAL

Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA

Drug: intra-arterial tenecteplase administration

Interventions

intra-arterial tenecteplase administration DRUG

Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA.

intra-arterial tenecteplase administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification;
• The availability of informed consent.

You may not qualify if:

• Other sub-types of ischemic stroke such as cardioembolism.
• Hemorrhagic stroke such as cerebral hemorrhage, subarachnoid hemorrhage.
• Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<100000/mm3).
• 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.
• Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).
• Patients allergic to any ingredient of drugs in our study.
• Unsuitable for this clinical studies assessed by researcher.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

Location

Related Publications (1)

• Zhao ZA, Qiu J, Wang L, Zhao YG, Sun XH, Li W, Liu X, Li XL, Liu L, Chen MR, Chen HS. Intra-arterial tenecteplase is safe and may improve the first-pass recanalization for acute ischemic stroke with large-artery atherosclerosis: the BRETIS-TNK trial. Front Neurol. 2023 Apr 18;14:1155269. doi: 10.3389/fneur.2023.1155269. eCollection 2023.

  PMID: 37143999 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 17, 2019
• Study Start: December 15, 2019
• Primary Completion: August 20, 2021
• Study Completion: November 22, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

CN (1)