Evaluating the DERIVO® 2heal® Embolisation Device for treating intracranial aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DERIVO® 2heal® trial is a post-market clinical follow-up study assessing the safety and efficacy of the DERIVO® 2heal® Embolisation Device in treating intracranial aneurysms. Conducted in Germany across approximately 15 sites, this prospective, single-arm, open-label study will collect data on technical success, safety, and clinical outcomes over a period of 36 months for patient enrollment and an additional 12 months for follow-up. The study aims to identify any residual risks associated with the device and ensure its long-term performance in clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient to be treated with DERIVO® 2heal® Embolisation Device due to intracranial aneurysm according to IFU
* Age \> 18 years
* Signed Informed Consent Form
* Patient scheduled to be treated for only one target aneurysm except multiple aneurysms located in the same target zone to be treated with one DERIVO® 2heal® Embolisation Device
* Effective use of antiplatelet medication confirmed by applicable testing method according to local standard

Exclusion Criteria:

* Previously treated aneurysms with flow diverter, stent or WEB device
* Treatment as preparation for the flow-diversion treatment does not lead to exclusion of the patient
* Patient with a ruptured aneurysm in the acute phase of bleeding
* Pre-treatment disability (mRS \> 2)
* Aneurysms related to pre-existing arteriosclerotic vascular disease in the target vessel
* Contraindication against treatment with anti-platelet medication
* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study
* Participating in another study

Where it's running

• Universitätsklinikum Augsburg
  Augsburg, Germany Recruiting
• Charité - Universitätsmedizin Berlin
  Berlin, Germany Recruiting
• Klinikum Bremerhaven-Reinkenheide
  Bremerhaven, Germany Recruiting
• Universitätsklinikum Köln
  Cologne, Germany Recruiting
• Universitätsklinikum Carl Gustav Carus Dresden
  Dresden, Germany Recruiting
• Universitätsklinikum Düsseldorf
  Düsseldorf, Germany Recruiting

Study contacts

• Study coordinator: Acandis GmbH
• Email: info@acandis.com
• Phone: Tel: +49 7231 155 00 0

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How blood flow changes after flow-diverter treatment for brain aneurysms

  We will test whether combining 3D angiography and transcranial Doppler can identify blood-flow thresholds linked to narrowing inside flow-diverter stents in adults treated for brain aneurysms.

  Recruiting Zhujiang Hospital · Guangzhou, Guangdong · NCT06448949

• Flow Diverter Stent for Intracranial Aneurysm in China

  This study tests a novel flow diverter stent to treat intracranial aneurysms in adults and follows patients through treatment and follow-up.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07821957

• Surface-modified Flow Diverters for Unruptured Intracranial Aneurysms

  This study tests two surface-modified flow diverters, PED Shield and LFD, to see which better lowers ischemic complications in adults with unruptured intracranial aneurysms.

  Recruiting Henan Provincial People's Hospital · Zhengzhou, Henan · NCT07674004

• Real-World Experience With the WEB Device for Intracranial Aneurysms

  This study tests how well the Woven EndoBridge device works in routine treatment of intracranial aneurysms in China across multiple centers.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07620626

• Choydar flow-directed mesh stent for unruptured brain aneurysms

  This trial tests the Choydar flow-directed mesh stent to see if it is safe and works for people with unruptured intracranial aneurysms in the internal carotid or vertebral arteries.

  Recruiting at 8 sites Johnson & Johnson Medical (Shanghai) Ltd. · Chenzhou and 7 other locations · NCT07228312

• Pivotal test of the Silk Vista Baby Flow Diverter for unruptured brain aneurysms

  This study tests whether the Silk Vista Baby flow diverter can safely and effectively treat a single unruptured intracranial aneurysm in adults 22–80 years old.

  Recruiting at 6 sites Balt USA · Thousand Oaks, California and 5 other locations · NCT07225075

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.