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

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400940
• Other study ID #: D-ASIA
• Status: Recruiting
• Phase: Phase 4
• Start date: August 17, 2023
• Est. completion date: August 2028

Study information

• Verified date: May 2024
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: August 2028
• Est. primary completion date: August 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Drug:
• ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).
Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).
• combination of clopidogrel (tablets, 75 mg) and acetylsalicylic acid (ASA, tablets, 100 mg) or a combination of ticagrelor (tablets, 180 mg) and ASA (tablets, 100 mg).
Double antiplatelet (antithrombotic) therapy (DAT), including a combination of clopidogrel (tablets, 75 mg) and acetylsalicylic acid (ASA, tablets, 100 mg) or a combination of ticagrelor (tablets, 180 mg) and ASA (tablets, 100 mg).

Locations

Country	Name	City	State
Russian Federation	V.A. Almazov Fnmrc	Saint-petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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:	proper fit of the device for deflecting the flow to the walls in the carrier vessel; the gap between the flow deflection device and the vessel wall is < 25% of the vessel diameter; the gap between the flow deflection device and the vessel wall is > 25% of the vessel diameter.; proper fit of the device for deflecting the flow to the walls in the carrier vessel; the gap between the flow deflection device and the vessel wall is < 25% of the vessel diameter; the gap between the flow deflection device and the vessel wall is > 25% of the vessel diameter.; proper fit of the device for deflecting the flow to the walls in the carrier vessel;	For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
Other	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:	? the gap between the flow deflection device and the vessel wall is < 25% of the vessel diameter;	For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
Other	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:	? the gap between the flow deflection device and the vessel wall is > 25% of the vessel diameter.	For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
Other	Clinical safety parameters:	? the frequency of sensitivity to Double antiplatelet (antithrombotic) therapy or antiplatelet (antithrombotic) monotherapy according to the data of analyzer VerifyNow platelet testing and LTA platelet testing in patients of Mongoloid or Caucasoid races;	through study completion, an average of 1,5 year
Other	Clinical safety parameters:	? the frequency of neurological disorders immediately after implantation of a flow- diverting stent;	through study completion, an average of 1,5 year
Other	Clinical safety parameters:	? the frequency of bleeding and other AE caused by concomitant antithrombotic therapy;	through study completion, an average of 1,5 year
Other	Clinical safety parameters:	? the frequency of acute cerebral circulation disorders in the medium-term (3-6 months) and long-term (12-18 months) postoperative period;	through study completion, an average of 1,5 year
Other	Clinical safety parameters:	? frequency of deaths;	through study completion, an average of 1,5 year
Other	Clinical safety parameters:	the frequency of other Adverse Events and Serious Adverse Events	through study completion, an average of 1,5 year
Other	Angiographic safety parameters based on Digital subtraction angiography (DSA)	? the frequency of complications associated with the intervention - stent opening, stent apposition to the vessel wall, thrombosis, thromboembolism, blockage of vascular branches affected by aneurysm.	through study completion, an average of 1,5 year
Primary	Composite primary endpoint:	The proportion of favorable clinical outcomes corresponding to 0-2 points on the modified Rankin Scale (mRS) for assessing clinical status in the medium-term (3-6 months) and long-term (12-18 months) postoperative period.	For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
Secondary	Secondary endpoints:	? the proportion of technically successful stent implantations in the optimal position relative to the total number of treatment attempts using flow-diverting stents;	For all randomized participants up to 2 weeks
Secondary	Secondary endpoints:	? the average amount of time required to install a flow-diverting stent;	For all randomized participants up to 2 weeks
Secondary	Secondary endpoints:	? the change in the clinical status on the modified Rankin Scale (mRS) scale (0(no symptoms)-6 (death)) at the time of discharge compared with the value of the indicator at the screening.	baseline/discharge