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

Not Applicable

• Conditions: Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion
• Interventions: Device: DiVeRt

• Registration Number: NCT04589585
• Lead Sponsor: Merlin MD Pte Ltd

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.

Study Timeline

• Study Start: 2019-06-10
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DiVeRt treatment	DiVeRt	DiVeRt device to be used in the single arm

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
In-stent stenosis (DSA)	6 months	Evaluation of perforator vessel patency immediately post-implantation

Trial Locations

Locations (1)

Vall De Hebron; 🇪🇸 Barcelona, Spain