Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Merlin's DiVeRt-Vascular Reconstruction Device: a Prospective, Single Arm, Non-randomized, Open Label Study to Assess Safety and Performance

Conditions
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Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion

Intervention / Treatment
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* Device: DiVeRt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DiVeRt treatment<br>DiVeRt device to be used in the single arm | Device: DiVeRt<br>* DiVeRt - Vascular Reconstruction Device and Delivery System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 
| Incidence of unsuccessful Divert placement | Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events. | 3 months | 
| Aneurysm Occlusion Grading: MRRC scale | Evaluation of degree of aneurysm occlusion or degree of delayed opacification | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent stenosis (DSA) | Evaluation of perforator vessel patency immediately post-implantation | 6 months |