Clinical Study of Merlin's DiVeRt - Vascular Reconstructi... | NCT04589585

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

NCT04589585

Sponsor

Merlin MD Pte Ltd

Status

Unknown status

Last Update Posted

Apr 27, 2022Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

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

Interventions

DiVeRt

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2019Actual

Primary Completion Date

Sep 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Sep 14, 2020

First Submission Date that Met QC Criteria

Oct 14, 2020

First Posted Date

Oct 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2022

Last Update Posted Date

Apr 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DiVeRt treatment	Experimental	DiVeRt device to be used in the single arm	Device: DiVeRt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DiVeRt	Device	DiVeRt - Vascular Reconstruction Device and Delivery System	DiVeRt treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sweta Mrs Singh, Masters	Contact	68920020	135	ssingh@merlinmedical.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vall De Hebron	Recruiting	Barcelona		08035	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002532	Intracranial Aneurysm

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided