Database of stroke patients treated with thrombectomy
REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion
This study is creating a database to help understand how well a procedure called thrombectomy works for stroke patients and what factors might affect its success.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05311605 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a clinical and advanced imaging database for acute ischemic stroke patients who have undergone mechanical thrombectomy due to large vessel occlusion in the anterior circulation within 24 hours of stroke onset. It will involve a multi-center, prospective registry cohort study across various stroke centers in China, enrolling approximately 1600 patients. The study will also analyze predictors and mechanisms of futile recanalization after the procedure, utilizing both prospective and retrospective data.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with confirmed large vessel occlusion and who have undergone necessary imaging within the specified time frame.
Not a fit: Patients with a history of certain medical conditions or those unable to undergo imaging or receive contrast agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of treatment outcomes and optimize mechanical thrombectomy protocols for stroke patients.
How similar studies have performed: Previous studies like DAWN and DEFUSE 3 have shown success in extending the time window for mechanical thrombectomy, but this study aims to provide real-world evidence within that timeframe.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Older than 18 years; * Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy * Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2) confirmed by CTA or MRA, planned to receive or received stenting or aspiration thrombectomy * Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture was ≥6 hours) * mRS score ≤2 before admission * Informed consent obtained for longitudinal enrolled patients, waived of consent for retrospectively included cases Exclusion Criteria: * Had a history of infective disease, immunity disease, radiotherapy at head or neck, carotid dissection or other carotid disease. * Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal implants or claustrophobia, etc. * Unable to be injected with contrast agent due to allergy, renal dysfunction, etc. * Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months) * Already participated in other drug trials
Where this trial is running
Beijing
- Yunyun Xiong — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yunyun Xiong, MD, PhD — Beijing Tiantan Hospital
- Study coordinator: Yunyun Xiong, MD, PhD
- Email: xiongyunyun@bjtth.org
- Phone: 00861059975213
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.