Post Market Clinical Follow-Up Study of the Derivo® Embolisation Device

• Conditions: incidental intracranial aneurysms; I67.1; Cerebral aneurysm, nonruptured

• Registration Number: DRKS00006103
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-08
• Study Completion: 2019-10-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Patients with intracranial aneurysms deemed treatable with the Derivo® flow-diverter
2. The target aneurysm cannot be treated with other endovascular techniques or there is a higher treatment risk with other endovascular or neurosurgical techniques. (= treatment within intended use)
3. The patients have read and understood the informations with respect to the study and have given their consent prior to aneurysm treatment with the Derivo® flow-diverter.
4. Modified Rankin score of 0 or 1

Exclusion Criteria

1. Patients < 18 years of age
2. Patients with aneurysms related to arteriovenous malformations
3. Patients with known contraindications to antiplatelet therapy and/or anticoagulant therapy.
4. Pregnant or breast-feeding patients
5. Patients with confirmed subarachnoidal bleeding within the last two months
6. Patients likely to be unable to attend clinical and angiographic follow-up at 6 and 18 months
7. Patients with a contraindication according to the Instructions for use
- The size of the aneurysm and/or the size of the aneurysma forming vessel is not within the indicated area.
- An angiographically inappropriate vascular anatomy or vascular aberration for endovascular treatment.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Score (mRS) at 18 months