NCT04589585

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

4.3 years

First QC Date

September 14, 2020

Last Update Submit

April 25, 2022

Conditions

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

Outcome Measures

Primary Outcomes (3)

  • 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

  • Incidence of unsuccessful Divert placement

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

    3 months

  • Aneurysm Occlusion Grading: MRRC scale

    Evaluation of degree of aneurysm occlusion or degree of delayed opacification

    3 months

Secondary Outcomes (1)

  • In-stent stenosis (DSA)

    6 months

Study Arms (1)

DiVeRt treatment

EXPERIMENTAL

DiVeRt device to be used in the single arm

Device: DiVeRt

Interventions

DiVeRtDEVICE

DiVeRt - Vascular Reconstruction Device and Delivery System

DiVeRt treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall De Hebron

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Central Study Contacts

Sweta Mrs Singh, Masters

CONTACT

68920020ssingh@merlinmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

October 19, 2020

Study Start

June 10, 2019

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)