Investigating vessel perforation during thrombectomy for stroke treatment
PeRforation EVents During ENdovascular Therapy for Acute Ischemic Stroke (PREVENT) - Registry
This study looks at complications from thrombectomy procedures for stroke, specifically vessel perforations, to see what causes them and how to improve safety and treatment for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT06394180 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze complications arising from thrombectomy procedures for acute ischemic stroke, specifically focusing on vessel perforations. Researchers will identify factors that increase the likelihood of these perforations and examine imaging data to understand their causes. The study seeks to develop a classification system for these events to aid in immediate treatment decisions and improve overall safety during thrombectomy. By comparing outcomes between patients with and without perforations, the study hopes to enhance emergency responses and treatment protocols.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who experience acute ischemic stroke requiring thrombectomy and have evidence of vessel perforation.
Not a fit: Patients with documented rejection or those with both ischemic stroke and intracranial hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and outcomes for patients undergoing thrombectomy for acute ischemic stroke.
How similar studies have performed: While there have been studies on thrombectomy complications, this specific focus on vessel perforation is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years at time of thrombectomy * Acute ischemic stroke with occlusion of one or several intracranial arteries and subsequent thrombectomy. * Target cohort: Occurrence of intracranial perforation during thrombectomy with evidence of contrast extravasation in at least one diagnostic angiography series. * Comparison cohort: No perforation during thrombectomy. Every patient in the comparison group is matched to one patient in the target population. Matching will be carried out with respect to age, gender, participating center and location of the vascular occlusion. Exclusion Criteria: * Presence of a documented rejection * Presence of both ischemic stroke and intracranial hemorrhage on pre-interventional imaging. * Patients with intracranial dissection without active contrast extravasation. * Patients with rupture of a pre-existing intracranial aneurysm during thrombectomy. * Patients with contrast medium extravasation into a venous space instead of free contrast medium extravasation, e.g. the cavernous sinus with consecutive development of a carotid-cavernous fistula.
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Victor Schulze-Zachau, MD — University Hospital, Basel, Switzerland
- Study coordinator: Victor Schulze-Zachau, MD
- Email: Victor.schulze-zachau@usb.ch
- Phone: +41 61 328 56 32
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.