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

NCT04589585 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-04-27

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

DiVeRt

DiVeRt - Vascular Reconstruction Device and Delivery System

Sponsors & Collaborators

  • Merlin MD Pte Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2023-09-30
Completion
2023-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04589585 on ClinicalTrials.gov