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

Merlin MD Pte Ltd25 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 3 months

Incidence of unsuccessful Divert placement

Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events.

Time frame: 3 months

Aneurysm Occlusion Grading: MRRC scale

Evaluation of degree of aneurysm occlusion or degree of delayed opacification

Time frame: 3 months

Secondary Outcomes

In-stent stenosis (DSA)

Evaluation of perforator vessel patency immediately post-implantation

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts