NCT06394180 PeRforation EVents During ENdovascular Therapy for Acute Ischemic Stroke
| NCT ID | NCT06394180 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Periprocedural Vessel Perforation |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-12-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A large, worldwide study called PREVENT is looking at a complication that can happen during a stroke treatment called thrombectomy. This complication is a perforation of a blood vessel. The investigators aim to: 1. Find what factors make this perforation more likely. 2. Understand why the perforation happens by looking closely at images taken during the procedure. 3. Create a simple way to classify these perforations to help doctors decide how to treat them right away. 4. Improve the emergent treatment of vessel perforation to stop the bleeding rapidly. 5. Provide data to guide decision whether thrombectomy should be continued or aborted after the event of vessel perforation. 6. Develop a safer way to perform thrombectomy. Investigators will compare the results collected for patients where perforation happened with those where perforation did not happen.
Eligibility 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.
Contact & Investigator
Victor Schulze-Zachau, MD
PRINCIPAL INVESTIGATOR
University Hospital, Basel, Switzerland
Frequently Asked Questions
Who can join the NCT06394180 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periprocedural Vessel Perforation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06394180 currently recruiting?
Yes, NCT06394180 is actively recruiting participants. Contact the research team at Victor.schulze-zachau@usb.ch for enrollment information.
Where is the NCT06394180 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06394180 clinical trial?
NCT06394180 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Victor Schulze-Zachau, MD at University Hospital, Basel, Switzerland. The trial plans to enroll 1,000 participants.