Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System
NCT ID: NCT04589585
Last Updated: 2022-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2019-06-10
2023-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DiVeRt treatment
DiVeRt device to be used in the single arm
DiVeRt
DiVeRt - Vascular Reconstruction Device and Delivery System
Interventions
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DiVeRt
DiVeRt - Vascular Reconstruction Device and Delivery System
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Merlin MD Pte Ltd
INDUSTRY
Responsible Party
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Locations
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Vall De Hebron
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VV0146
Identifier Type: -
Identifier Source: org_study_id
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