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

niversitätsklinikum Freiburg0 个研究点目标入组 102 人开始时间: 2014年10月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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.

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