International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

Active, not recruiting

• Conditions: Intracranial Aneurysm

• Registration Number: NCT04572230
• Lead Sponsor: Stryker Neurovascular

Brief Summary

IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.

Detailed Description

IMPACT is an international, prospective, observational, multicenter, non-randomized, post market study designed to provide ongoing safety and performance evaluation on implantable devices used for the treatment of intracranial aneurysms with an endovascular approach. Data collection will also include details on adjunctive and ancillary devices used.

In addition, to gaining safety and performance data, this study will provide clinical evidence that may assist physicians in selecting an appropriate device(s) while describing treatment options used to treat patients with intracranial aneurysms.

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-10-01
• Study Start: 2020-12-21
• Primary Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Performance Measure	12 months	Composite of 100% occlusion of the target aneurysm without significant parent artery stenosis per independent core lab assessment and with no target aneurysm retreatment
Primary Safety Endpoint	12 months	Stroke-related neurological death or Disabling stroke in the target vessel territory as adjudicated by an independent Clinical Events Committee (CEC)

Secondary Outcome Measures

Name	Time	Method
Secondary Performance Measures	Through 24 months	Target aneurysm recanalization, Parent artery stenosis ≥ 50%, Target aneurysm retreatment, Target aneurysm occlusion status, Aneurysm size evaluation
Secondary Safety Endpoints	Through 24 months	Procedural and device related serious adverse events, Any key neurological event of interest

Trial Locations

Locations (32)

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

Uniklinik Salzburg; 🇦🇹 Salzburg, Austria

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

CHU Amiens; 🇫🇷 Amiens, France

CHRU Besançon; 🇫🇷 Besançon, France

CHU Pellegrin Bordeaux; 🇫🇷 Bordeaux, France

CHU Cavale Blanche Brest; 🇫🇷 Brest, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Henri Mondor Créteil; 🇫🇷 Créteil, France

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