Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, LesionNCT04589585
Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System
A study testing DiVeRt in people with Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion, run by Merlin MD Pte Ltd at 1 site in Spain.
Trial summary
The objective of the proposed investigation is to assess the safety and effectiveness of the Merlin's DiVeRt system for the treatment of intracranial lesions. Merlin is a manufacturer of Flow- Diverters (FD) for Neurovascular applications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion
- What is being tested?
- DiVeRt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
- Age 18-80 years.
- Subject has a target intracranial aneurysm (IA) or a lesion located in the anterior or posterior circulation.
- Subject has a target IA with a wide or large neck aneurysm or a lesion. The aneurysm type includes saccular, fusiform, dissecting or blister shapes.
Who cannot join
- Major surgery in the last 30 days.
- History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
- NIH Stroke Scale ( NIHSS) greater than or equal to 4
- Any known contraindication to treatment with flow diverters.
- Pregnant women.
- Participating in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vall De Hebron
Barcelona, 08035
Alejandro Dr Tomasello, (+34) 93 489 30 00, alejandrotomasello@gmail.com
David Dr Hernandez, (+34) 93 489 30 00, dhm050780@gmail.com
About this study
Official title: Merlin's DiVeRt-Vascular Reconstruction Device: a Prospective, Single Arm, Non-randomized, Open Label Study to Assess Safety and Performance
The objective of the proposed investigation is to assess the safety and effectiveness of the Merlin's DiVeRt system for the treatment of intracranial lesions.
Merlin is a manufacturer of Flow- Diverters (FD) for Neurovascular applications. The technology is based on a microporous polymer membrane which is delivered to the site of lesion treatment using a metal stent scaffold. The first device in its FD family is the XCalibur Aneurysm Occlusion Device (AOD) system, which is delivered on a rapid-exchange balloon catheter which goes in a 6-Fr guide-catheter. The AOD is CE-marked and has been involved in the treatment of over 70 clinical lesion/aneurysm cases. The same technology is now being made available in a self-expandable stent platform delivered on a 0.028" microcatheter. Merlin has performed the required in-silico, in-vitro and in-vivo tests to be confident of the device performance and now intends to proceed to the human clinical-trials. DiVeRt (Interventional) is a non CE mark device. The device is under clinical trial phase. The competent authority submission for the study has been completed in Spain, Turkey and Hungary.
Read the detailed description
The study will recruit patients with intracranial aneurysm (IA) or a lesion located in the anterior or posterior circulation. The analyses of the data from this safety and feasibility study will be descriptive.
- Being tested
- DiVeRt
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiVeRtDevice
DiVeRt - Vascular Reconstruction Device and Delivery System
| Study group | Role | What they receive |
|---|---|---|
| DiVeRt treatment | Experimental | DiVeRt device to be used in the single arm Receives: Device: DiVeRt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all serious adverse events assessed, clinically or angiographically
Serious Adverse events will be evaluated as device-related, procedure-related, or unrelated to the procedure or the device
Measured: 3 months
Incidence of unsuccessful Divert placement
Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events.
Measured: 3 months
Aneurysm Occlusion Grading: MRRC scale
Evaluation of degree of aneurysm occlusion or degree of delayed opacification
Measured: 3 months
Secondary outcomes (1)
In-stent stenosis (DSA)
Evaluation of perforator vessel patency immediately post-implantation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start10 Jun 2019
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, LesionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merlin MD Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589585
- Sponsor's protocol ID
- VV0146
- Status last verified
- Apr 2022
- First submitted
- 14 Sep 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Merlin's DiVeRt-Vascular Reconstruction Device: a Prospective, Single Arm, Non-randomized, Open Label Study to Assess Safety and Performance
- ClinicalTrials.gov ID
- NCT04589585
- Acronym / sponsor ID
- VV0146
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Merlin MD Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 19 Oct 2020 (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.
The objective of the proposed investigation is to assess the safety and effectiveness of the Merlin's DiVeRt system for the treatment of intracranial lesions.
Merlin is a manufacturer of Flow- Diverters (FD) for Neurovascular applications. The technology is based on a microporous polymer membrane which is delivered to the site of lesion treatment using a metal stent scaffold. The first device in its FD family is the XCalibur Aneurysm Occlusion Device (AOD) system, which is delivered on a rapid-exchange balloon catheter which goes in a 6-Fr guide-catheter. The AOD is CE-marked and has been involved in the treatment of over 70 clinical lesion/aneurysm cases. The same technology is now being made available in a self-expandable stent platform delivered on a 0.028" microcatheter. Merlin has performed the required in-silico, in-vitro and in-vivo tests to be confident of the device performance and now intends to proceed to the human clinical-trials. DiVeRt (Interventional) is a non CE mark device. The device is under clinical trial phase. The competent authority submission for the study has been completed in Spain, Turkey and Hungary.
Detailed description
The study will recruit patients with intracranial aneurysm (IA) or a lesion located in the anterior or posterior circulation. The analyses of the data from this safety and feasibility study will be descriptive.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DiVeRt treatment | Experimental | Device: DiVeRtDiVeRt device to be used in the single arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
- Age 18-80 years.
- Subject has a target intracranial aneurysm (IA) or a lesion located in the anterior or posterior circulation.
- Subject has a target IA with a wide or large neck aneurysm or a lesion. The aneurysm type includes saccular, fusiform, dissecting or blister shapes.
Key exclusion criteria (6 listed)
- Major surgery in the last 30 days.
- History of irreversible bleeding disorder and/or subject presents with signs of active bleeding.
- NIH Stroke Scale ( NIHSS) greater than or equal to 4
- Any known contraindication to treatment with flow diverters.
- Pregnant women.
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 |
|---|---|---|
| DiVeRtDiVeRt - Vascular Reconstruction Device and Delivery System | Device | DiVeRt treatment |
Primary outcome
Incidence of all serious adverse events assessed, clinically or angiographically
Time frame: 3 months
Serious Adverse events will be evaluated as device-related, procedure-related, or unrelated to the procedure or the device
Incidence of unsuccessful Divert placement
Time frame: 3 months
Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events.
Aneurysm Occlusion Grading: MRRC scale
Time frame: 3 months
Evaluation of degree of aneurysm occlusion or degree of delayed opacification
1 secondary outcome
In-stent stenosis (DSA)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion
RecruitingObservational study
Microvention AnEurysm & STroke Real-life Data cOllection
Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiVeRt in people with Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion, run by Merlin MD Pte Ltd at 1 site in Spain.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. 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 Spain. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sweta Mrs Singh, Masters (68920020 ext. 135, ssingh@merlinmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all serious adverse events assessed, clinically or angiographically (time frame: 3 months). The study lists 3 primary outcomes in all. 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 27 Apr 2022.