CompletedNot Applicable

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

Germany21 participantsStarted 2021-09-09

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged ≥18 years * Unruptured, saccular aneurysm of the internal carotid artery (ICA) suitable for single-device flow diverter treatment * Availability of angiographic follow-up imaging at both 3 and 9 months Exclusion Criteria: * Fusiform or dissecting aneurysms * Requirement for multiple flow diverter implantation * Previous treatment of the target aneurysm * Contraindications to dual antiplatelet therapy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

In-Stent Stenosis Severity (Ratio-Based Luminal Narrowing)

Timeframe: 3 months and 9 months after the procedure (DSA follow-up)

Trial details

NCT IDNCT07420179

SponsorUniversität des Saarlandes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Aneurysm Cerebral trials