Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)

Launched by GENERAL HOSPITAL OF SHENYANG MILITARY REGION · Dec 10, 2022

Keywords

ClinConnect Summary

The BRETIS-TNK II trial is studying a treatment for patients who have had an acute ischemic stroke caused by a blockage in a major blood vessel in the brain. The researchers want to find out if giving a medication called tenecteplase (TNK) directly into the artery during the first attempt to remove the blockage can help restore blood flow more effectively and lead to better recovery outcomes. This trial is currently recruiting participants aged 18 and older who meet specific criteria, including having a certain type of stroke and a reasonably good health status before the stroke.

If you join this study, you'll be part of an important effort to test whether this treatment is safe and works well. Participants will receive close monitoring during the procedure, and your experience will help doctors learn more about the best ways to treat strokes in the future. It's important to note that not everyone will be eligible to participate; for example, those with certain health conditions, such as severe kidney problems or other types of strokes, cannot join. Overall, this trial aims to improve stroke treatment and outcomes for patients like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years;
• • Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
• • The modified Rankin Scale (mRS) score before onset ≤ 2;
• • ASPECTS 6 or greater on CT
• • Signed informed consent.
• Exclusion Criteria:
• • hemorrhagic stroke;
• • Tandem occlusion;
• • 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), elevated 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 with contraindication or allergic to any ingredient of drugs in our study;
• • Pregnancy, or plan to get pregnant or during active lactation;
• • Suspected septic embolus or infective endocarditis
• • The estimated life expectancy is less than 6 months due to other serious diseases;
• • Other conditions unsuitable for this clinical study as assessed by researcher.