Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia

Recruiting now · Phase 4

Conditions studied: Intracranial Aneurysm

In brief

Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia

Key facts

Study ID

NCT06400940

Run by

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

People needed

640

Starts

2023-08-17

Expected to finish

2028-08-01

Last updated by the study team

2024-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• localization and structure of the aneurysm allows the use of a DERIVO®/DERIVO® mini flow-diverting stent for treatment;
• the aneurysm cannot be cured by other methods of endovascular therapy, or there is a higher risk of complications when using other methods of endovascular therapy or microsurgery;
• clipping or embolization with spirals (if performed earlier) led to a recurrence of the aneurysm.

You may not qualify if…

• Age less than 18 years.
• Pregnancy.
• The presence of a previously implanted stent in a cerebral artery.
• Dissection of cerebral or peripheral vessels.
• The presence of contraindications to the use of the DERIVO®/DERIVO® mini medical device, specified in the instructions for use:
• non-compliance of the aneurysm and/or the carrier vessel with the indications for the use of the device;
• non-physiological structure of cerebral vessels;
• vascular disorders that are a contraindication to endovascular interventions.
• The presence of contraindications for antiplatelet (antithrombotic) and/or anticoagulant therapy in accordance with the instructions for the medical use of drugs.

Where it is running

• V.A. Almazov Fnmrc — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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