Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion Clinical Trial
Official title:
Merlin's DiVeRt-Vascular Reconstruction Device: a Prospective, Single Arm, Non-randomized, Open Label Study to Assess Safety and Performance
| NCT number | NCT04589585 |
| Other study ID # | VV0146 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 10, 2019 |
| Est. completion date | December 30, 2023 |
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.
| Status | Recruiting |
| Enrollment | 25 |
| Est. completion date | December 30, 2023 |
| Est. primary completion date | September 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Vall De Hebron | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Merlin MD Pte Ltd |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Incidence of unsuccessful Divert placement | Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events. | 3 months | |
| Primary | Aneurysm Occlusion Grading: MRRC scale | Evaluation of degree of aneurysm occlusion or degree of delayed opacification | 3 months | |
| Secondary | In-stent stenosis (DSA) | Evaluation of perforator vessel patency immediately post-implantation | 6 months |