Clinical Trial

Derivo 2 Heal vs Derivo 2: In-Stent Stenosis After Flow Diversion

Completed
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Summary
The goal of this clinical trial is to learn whether a coated flow diverter leads to fewer in-stent narrowings (in-stent stenosis) than an otherwise identical uncoated flow diverter when used to treat intracranial aneurysms in routine clinical care. The main questions it aims to answer are: Does the coated flow diverter reduce the rate and severity of in-stent stenosis compared with the uncoated flow diverter? Are there differences in angiographic aneurysm occlusion and procedure-related complications between the two devices? Researchers will compare treatment with the coated flow diverter (Derivo 2 heal) to the uncoated flow diverter (Derivo 2). Participants will: Receive endovascular treatment of their intracranial aneurysm with one of the two flow diverters assigned by randomization Receive standard antiplatelet medication and follow-up imaging as part of routine care
Trial Details
NCT Number NCT07420179
Lead Sponsor Universität des Saarlandes
Conditions Aneurysm Cerebral
Enrollment 21 participants
Start Date 2021-09-09
Primary Completion 2025-04-01 (estimated)
Study Completion 2025-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-19