Neurovascular Product Surveillance Registry

Recruiting

• Conditions: Intracranial Aneurysm; Stroke, Ischemic

• Registration Number: NCT02988128
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

Brief Summary

Post market surveillance registry

Detailed Description

An observational, prospective, multi-center, single-arm registry to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic Neurovascular market-released products used in the treatment of Intracranial aneurysms and Acute Ischemic Stroke.

MDT16056 and MDT17077 are conducted under the Product Surveillance Registry (NCT01524276).

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-09
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-11
• Primary Completion: 2032-08
• Study Completion: 2032-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
• Patient has, or is intended to receive or be treated with, an eligible Medtronic product
• Patient is consented within the enrollment window of the therapy received, as applicable
• Patient is at least 18 years of age at time of enrollment.

Exclusion Criteria

• Patient who is, or is expected to be inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
• Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.

For MDT24028 and MDT22032:

General Inclusion Criteria:

• Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
• Patient is treated or intended to be treated with an eligible Medtronic Neurovascular product.
• Patient is an adult per local law at time of consent. Medtronic Business Restricted This document is electronically controlled CONFIDENTIAL 056-F275 Rev F Clinical Investigation Plan Template

General Exclusion Criteria:

• Patient who may be unable to complete the study follow-up
• Patient with any contraindications per the applicable Instructions for Use document
• Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study
• Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.

Additional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Independence: mRS score ≤ 2	90 days	For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2
The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).	1 year	For Intracranial Aneurysm the primary outcome is the clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).

Trial Locations

Locations (98)

ENERI; 🇦🇷 Buenos Aires, Argentina

Gold Coast University Hospital; 🇦🇺 Southport, Australia

Universitätsklinikum Christian Doppler Klinik Salzburg; 🇦🇹 Salzburg, Austria

Ziekenhuis Oost Limburg - Campus Sint-Jan; 🇧🇪 Genk, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China

Chongqing University Three Gorges Hospital; 🇨🇳 Chongqing, China

The Affiliated Hospital of Jinggangshan University; 🇨🇳 Ji'an, China

First Affiliated Hospital of Jiamusi University; 🇨🇳 Jiamusi, China

Kaifeng Central Hospital; 🇨🇳 Kaifeng, China

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