DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device

Launched by ACANDIS GMBH · Sep 14, 2022

Keywords

ClinConnect Summary

The DERIVO® 2heal® Study is a clinical trial designed to evaluate the safety and effectiveness of a new device called the DERIVO® 2heal® Embolisation Device, which is used to treat intracranial aneurysms. An intracranial aneurysm is a weak spot in a blood vessel in the brain that can potentially burst, leading to serious health issues. This study aims to find out how well this device works over time in helping patients with this condition.

To participate in the study, patients must be over 18 years old and scheduled to be treated for a single aneurysm (or multiple aneurysms in the same area) using the DERIVO® device. They also need to be able to take certain medications that prevent blood clots. However, people who have had previous treatments for their aneurysms, have a ruptured aneurysm, or have certain medical conditions may not be eligible. Participants will receive the treatment as part of their standard care, and their progress will be monitored to see how well the device works and how safe it is over the following months and years. If you or a loved one may qualify, this study could provide valuable information about a new option for treating aneurysms.

Gender

ALL

Eligibility criteria

• 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