Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion
Conditions
Brief 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. 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.
Interventions
DEVICEDiVeRt
DiVeRt - Vascular Reconstruction Device and Delivery System
Sponsors
Merlin MD Pte Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all serious adverse events assessed, clinically or angiographically | 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 | 3 months | Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events. |
| Aneurysm Occlusion Grading: MRRC scale | 3 months | Evaluation of degree of aneurysm occlusion or degree of delayed opacification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-stent stenosis (DSA) | 6 months | Evaluation of perforator vessel patency immediately post-implantation |
Countries
Spain
Contacts
Primary ContactSweta Mrs Singh, Masters
Outcome results
None listed