Clinical trial NCT06400940: Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia
Official title: Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Intracranial Aneurysm
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, post-registration, interventional, randomized, in parallel groups,
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

1. Age less than 18 years.
2. Pregnancy.
3. The presence of a previously implanted stent in a cerebral artery.
4. Dissection of cerebral or peripheral vessels.
5. 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.
6. The presence of contraindications for antiplatelet (antithrombotic) and/or anticoagulant therapy in accordance with the instructions for the medical use of drugs.

Primary outcomes:
measure: Composite primary endpoint:
timeFrame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
Secondary outcomes:
measure: Secondary endpoints:
timeFrame: For all randomized participants up to 2 weeks
measure: Secondary endpoints:
timeFrame: For all randomized participants up to 2 weeks
measure: Secondary endpoints:
timeFrame: baseline/discharge
Other outcomes:
measure: The technical success of stent implantation will be evaluated based on Digital subtraction angiography (DSA) on the fit of the flow-diverting stent to the wall of the carrier vessel according to the following criteria:
timeFrame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
measure: The technical success of stent implantation will be evaluated based on Digital subtraction angiography (DSA) on the fit of the flow-diverting stent to the wall of the carrier vessel according to the following criteria:
timeFrame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
measure: The technical success of stent implantation will be evaluated based on Digital subtraction angiography (DSA) on the fit of the flow-diverting stent to the wall of the carrier vessel according to the following criteria:
timeFrame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
measure: Clinical safety parameters:
timeFrame: through study completion, an average of 1,5 year
measure: Clinical safety parameters:
timeFrame: through study completion, an average of 1,5 year
measure: Clinical safety parameters:
timeFrame: through study completion, an average of 1,5 year
measure: Clinical safety parameters:
timeFrame: through study completion, an average of 1,5 year
measure: Clinical safety parameters:
timeFrame: through study completion, an average of 1,5 year
measure: Clinical safety parameters:
timeFrame: through study completion, an average of 1,5 year
measure: Angiographic safety parameters based on Digital subtraction angiography (DSA)
timeFrame: through study completion, an average of 1,5 year
Locations:
city: Saint-petersburg
country: Russian Federation
facility: V.A. Almazov Fnmrc
Study officials:
References: