Microvention AnEurysm & STroke Real-life Data cOllection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMicrovention-Terumo, Inc.

About this trial

The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient, or another authorized person as per country-specific regulations, is informed of the data collection and gives non-opposition or consent prior to the data collection in accordance with institutional and geographic requirements.

For Cohort 1, patient is treated for a ruptured or unruptured intracranial aneurysm using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the MAESTRO study.

For Cohort 2, patient is treated using a commercially available MicroVention mechanical thrombectomy device as the first-line treatment strategy and the decision to use this device has been made by the treating physician outside the context of the MAESTRO study.

Disqualifiers

Patient is or is expected to be inaccessible for follow-up.

Patient is participating or intends to participate in another study that changes the site practice.

Patient is already participating in the MAESTRO study for the same pathology.

Trial population

* Cohort 1: Patients with ruptured or unruptured intracranial aneurysms who are treated endovascularly with commercially available MicroVention implant devices at the direction of the treating physician * Cohort 2: Patients with acute ischemic stroke in the cerebral circulation who are treated with mechanical thrombectomy using selected commercially available Microvention devices, at the direction of the treating physician.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • All Microvention Class III implantable device CE marked

    Device

    Endovascular treatment of ruptured or unruptured intracranial aneurysms with commercially available MicroVention implant devices.

  • All Microvention Mechanical Thrombectomy Class III device CE marked

    Device

    Endovascular treatment of acute ischemic stroke with commercially available MicroVention devices.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: 11 intervention
Group B: 21 intervention

Trial outcomes

Primary outcomes

1

Cohort 1: Proportion of aneurysms with complete occlusion

based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory

Time frame
18 (±6) months
2

Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization

based on independent Corelab assessment

Time frame
Mechanical trombectomy Procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

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