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

April 25, 2022 updated by: Merlin MD Pte Ltd

Merlin's DiVeRt-Vascular Reconstruction Device: a Prospective, Single Arm, Non-randomized, Open Label Study to Assess Safety and Performance

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DiVeRt treatment
DiVeRt device to be used in the single arm
Device: DiVeRt
DiVeRt - Vascular Reconstruction Device and Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all serious adverse events assessed, clinically or angiographically
Time Frame: 3 months
Serious Adverse events will be evaluated as device-related, procedure-related, or unrelated to the procedure or the device
3 months
Incidence of unsuccessful Divert placement
Time Frame: 3 months
Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events.
3 months
Aneurysm Occlusion Grading: MRRC scale
Time Frame: 3 months
Evaluation of degree of aneurysm occlusion or degree of delayed opacification
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-stent stenosis (DSA)
Time Frame: 6 months
Evaluation of perforator vessel patency immediately post-implantation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merlin MD Pte Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2019

Primary Completion (ANTICIPATED)

September 30, 2023

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (ACTUAL)

October 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VV0146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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