Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System
Primary Purpose
Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
DiVeRt
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion
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.
Sites / Locations
- Vall De HebronRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DiVeRt treatment
Arm Description
DiVeRt device to be used in the single arm
Outcomes
Primary Outcome Measures
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
Incidence of unsuccessful Divert placement
Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events.
Aneurysm Occlusion Grading: MRRC scale
Evaluation of degree of aneurysm occlusion or degree of delayed opacification
Secondary Outcome Measures
In-stent stenosis (DSA)
Evaluation of perforator vessel patency immediately post-implantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04589585
Brief Title
Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System
Official Title
Merlin's DiVeRt-Vascular Reconstruction Device: a Prospective, Single Arm, Non-randomized, Open Label Study to Assess Safety and Performance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merlin MD Pte Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DiVeRt treatment
Arm Type
Experimental
Arm Description
DiVeRt device to be used in the single arm
Intervention Type
Device
Intervention Name(s)
DiVeRt
Intervention Description
DiVeRt - Vascular Reconstruction Device and Delivery System
Primary Outcome Measure Information:
Title
Incidence of all serious adverse events assessed, clinically or angiographically
Description
Serious Adverse events will be evaluated as device-related, procedure-related, or unrelated to the procedure or the device
Time Frame
3 months
Title
Incidence of unsuccessful Divert placement
Description
Incidence of unsuccessful Divert placement leading to, or with the potential of leading to, adverse events.
Time Frame
3 months
Title
Aneurysm Occlusion Grading: MRRC scale
Description
Evaluation of degree of aneurysm occlusion or degree of delayed opacification
Time Frame
3 months
Secondary Outcome Measure Information:
Title
In-stent stenosis (DSA)
Description
Evaluation of perforator vessel patency immediately post-implantation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sweta Mrs Singh, Masters
Phone
68920020
Ext
135
Email
ssingh@merlinmedical.com
Facility Information:
Facility Name
Vall De Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Dr Tomasello
Phone
(+34) 93 489 30 00
Email
alejandrotomasello@gmail.com
First Name & Middle Initial & Last Name & Degree
David Dr Hernandez
Phone
(+34) 93 489 30 00
Email
dhm050780@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Merlin's DiVeRt - Vascular Reconstruction Device and Delivery System
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