Clinical trial NCT04589585: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm, Lesion
Lead sponsor: Merlin MD Pte Ltd
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of all serious adverse events assessed, clinically or angiographically
timeFrame: 3 months
measure: Incidence of unsuccessful Divert placement
timeFrame: 3 months
measure: Aneurysm Occlusion Grading: MRRC scale
timeFrame: 3 months
Secondary outcomes:
measure: In-stent stenosis (DSA)
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall De Hebron
Study officials:
References: