Improving treatment for ischemic stroke with poor blood flow after thrombectomy
Improving Neuroprotective Strategy for Ischemic Stroke With Poor Recanalization After Thrombectomy by Intra-arterial TNK (INSIST-TNK): a Prospective, Single Arm, Pilot Study
This study is testing whether giving a medication called tenecteplase after a procedure to remove a blood clot can help improve blood flow in stroke patients who didn't get enough recovery from the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 1 site (Shenyang) |
| Trial ID | NCT04201964 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intra-arterial tenecteplase in patients who have undergone thrombectomy for acute ischemic stroke but have not achieved sufficient blood flow restoration. It aims to determine the proportion of patients who achieve adequate recanalization after receiving tenecteplase, a thrombolytic agent, following thrombectomy. The study builds on previous findings that suggest tenecteplase may lead to better outcomes compared to alteplase when administered before thrombectomy. By focusing on patients with insufficient recanalization, this research seeks to provide new insights into improving treatment strategies for ischemic stroke.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute ischemic stroke with a large vessel occlusion and have insufficient perfusion after thrombectomy.
Not a fit: Patients who achieve sufficient recanalization after thrombectomy or have contraindications such as severe hemorrhagic conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery outcomes for patients with ischemic stroke who do not achieve sufficient blood flow restoration after thrombectomy.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shenyang
- General Hospital of Northern Theater Command — Shenyang, China (Recruiting)
Study contacts
- Study coordinator: Zi-Ai Zhao, Doctor
- Email: zhaoziai@hotmail.com
- Phone: +86 17790998175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.