Evaluating a new treatment for acute ischemic stroke after reperfusion
Oriental Research Alliance of Acute Ischemic Stroke Given Endovascular Treatment: Technique Feasibility, Safety and Neuroprotective Effects of in Situ Ischemic Postconditioning in Patients Underwent Successful Endovascular Thrombectomy
This study is testing a new treatment for adults who have had an acute ischemic stroke to see if a special balloon technique after blood flow restoration can improve their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital Academic / other |
| Locations | 2 sites (Zhangzhou, Fujian and 1 other locations) |
| Trial ID | NCT05024292 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of in situ ischemic postconditioning (ISIPC) in patients with acute ischemic stroke (AIS) who have undergone successful reperfusion through endovascular treatment. The approach involves performing five cycles of balloon inflations in the ipsilateral internal carotid artery immediately after reperfusion, with each cycle consisting of 15 seconds of inflation followed by 15 seconds of deflation. The study will include adult patients with specific criteria related to stroke severity and imaging results. It is observational in nature, focusing on the outcomes of this novel intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 95 with specific occlusions and stroke severity scores who have achieved successful reperfusion.
Not a fit: Patients with strokes of large artery atherosclerotic origin or those who have undergone rescue angioplasty or stenting may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for patients suffering from acute ischemic stroke.
How similar studies have performed: While this approach is novel, similar studies exploring postconditioning techniques have shown promising results in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,; 2. Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke; 3. Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value; 4. Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital 5. The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt Exclusion Criteria: 1. Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion; 2. Patients underwent rescue angioplasty or stenting after thrombectomy
Where this trial is running
Zhangzhou, Fujian and 1 other locations
- Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou, Fujian, China (Recruiting)
- Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yueqi Zhu, PhD
- Email: zhuyueqi@hotmail.com
- Phone: +86-21-18930177565
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.