Intracranial AneurysmPhase 4NCT06400940
Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia
A Phase 4 study testing ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). and 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). in people with Intracranial Aneurysm, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial summary
Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). and 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).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteRussia
- Study dates
- 17 Aug 2023to Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
V.A. Almazov Fnmrc
Saint Petersburg, 197341
Andrey E Petrov, MD, +79213333100, doctorpetrovandrey@gmail.com
Arkady A Ivanov, MD, +79818817426, arkady.neuro@gmail.com
About this study
Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia
Read the detailed description
Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia
- Conditions
- Intracranial Aneurysm
- Being tested
- 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).
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).Drug
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).Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Antiplatelet (antithrombotic) monotherapy | Experimental | Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). Receives: Drug: ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). |
| Double antiplatelet (antithrombotic) therapy | Active comparator | 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). Receives: Drug: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
Secondary outcomes (3)
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;
Measured: For all randomized participants up to 2 weeks
Secondary endpoints:
● the average amount of time required to install a flow-diverting stent;
Measured: For all randomized participants up to 2 weeks
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.
Measured: baseline/discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start17 Aug 2023
- Primary completion17 Aug 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, post-registration, interventional, randomized, in parallel groups,
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrey Evgenievich Petrov, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400940
- Sponsor's protocol ID
- D-ASIA
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia
- ClinicalTrials.gov ID
- NCT06400940
- Acronym / sponsor ID
- D-ASIA
- Conditions
- Intracranial Aneurysm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 17 Aug 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, post-registration, interventional, randomized, in parallel groups,
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet (antithrombotic) monotherapy | Experimental | Drug: ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). |
| Double antiplatelet (antithrombotic) therapy | Active comparator | Drug: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). | Drug | Antiplatelet (antithrombotic) monotherapy |
| 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). | Drug | Double antiplatelet (antithrombotic) therapy |
Primary outcome
Composite primary endpoint:
Time frame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
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.
3 secondary outcomes
Secondary endpoints:
Time frame: For all randomized participants up to 2 weeks
Secondary endpoints:
Time frame: For all randomized participants up to 2 weeks
Secondary endpoints:
Time frame: baseline/discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). and 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). in people with Intracranial Aneurysm, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint: (time frame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.