Using balloon dilation to improve recovery after acute ischemic stroke
Ischemic Post-conditioning in the Treatment of Acute Ischemic Stroke--a Multicenter, Prospective Cohort Study
This study is testing if a balloon technique can help people recovering from a severe stroke feel better and improve their brain function after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tianjin Huanhu Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06456437 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of ischemic post-conditioning, a technique involving repeated balloon dilation and contraction at the site of a large vessel occlusion, on patients undergoing mechanical thrombus extraction for acute ischemic stroke. The approach aims to reduce ischemia-reperfusion injury and enhance neurological recovery by inducing protective factors in the brain. Patients with confirmed ischemic stroke and large vessel occlusion will be monitored for outcomes following the intervention. The study seeks to provide insights into the safety and efficacy of this cerebroprotective strategy.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed ischemic stroke and large vessel occlusion who are undergoing mechanical thrombus extraction.
Not a fit: Patients with conditions that interfere with neurological assessment, severe illnesses, or those unable to undergo imaging studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve neurological recovery and reduce disability in patients with acute ischemic stroke.
How similar studies have performed: While the concept of ischemic post-conditioning has shown promise in animal models, its application in human subjects remains novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1)Ischemic stroke confirmed by CT or MRI of the head; * 2\) Large vessel occlusion confirmed by CTA or MRA of the head, including: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA), and posterior cerebral artery (PCA P1/P2); * 3\) Recanalization of the occluded vessel at eTICI grade 2b/3 as confirmed by DSA after thrombectomy; * 4)The patient/legally authorized representative has signed an informed consent form. Exclusion Criteria: * 1\) Inability to perform an MRI or CT scan for any reason; * 2）The patient has any condition that would interfere with neurologic assessment or psychiatric disorders; * 3）Stroke onset with seizures resulted in the inability to obtain an accurate NIHSS baseline; * 4）Pregnancy * 5）Other serious, advanced or terminal illness;
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Huanhu Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Ming Wei, doctorate — Tianjin Huanhu Hospital
- Study coordinator: Ming Wei, PhD
- Email: drweiming@163.com
- Phone: 13502182903
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.