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

IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Nguyet T Labenski; Phone Number: 978.941.8139; Email: nguyet.labenski@stryker.com
• Study Contact Backup: Name: Alice Lin; Email: alice.lin@stryker.com

Study Locations

• Austria
  • Salzburg, Austria
    • Uniklinik Salzburg
• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
  • Turku, Finland
    • Turku University Hospital
• France
  • Amiens, France
    • CHU Amiens
  • Besançon, France
    • CHRU Besançon
  • Bordeaux, France
    • CHU Pellegrin Bordeaux
  • Brest, France
    • CHU Cavale Blanche Brest
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand
  • Créteil, France
    • Henri Mondor Créteil
  • La Tronche, France
    • CHU la Tronche Grenoble
  • Lille, France
    • CHU Lille
  • Lyon, France
    • CHU Bron-Lyon
  • Marseille, France
    • CHU La Timone Marseille
  • Montpellier, France
    • CHU Montpellier
  • Nancy, France
    • CHU Nancy
  • Paris, France
    • La Pitié Salpêtrière
  • Paris, France
    • Hospital Fondation Rothschild - Paris
  • Paris, France
    • NEURI, Kremlin Bicêtre
  • Rennes, France
    • CHU Rennes
  • Rouen, France
    • CHU Charles Nicolle Rouen
  • Saint-Étienne, France
    • CHU Saint Etienne
  • Tours, France
    • CHU Bretonneau Tours
• Germany
  • Augsburg, Germany
    • Universitätsklinikum Augsburg A.ö.R
  • Bochum, Germany
    • University Hospital Knappschaftskrankenhaus Bochum
• Italy
  • Florence, Italy
    • AO Careggi Hospital
  • Genova, Italy
    • Ospedale Policlinico San Martino
  • Milan, Italy
    • Grande Ospedale Metropolitano Niguarda
  • Rome, Italy
    • Fondazione Policlinico Universitario A. Gemelli
• Switzerland
  • Bern, Switzerland
    • Inselspital Bern
  • Zürich, Switzerland
    • University Hospital of Zürich
• United Kingdom
  • Birmingham, United Kingdom
    • Queen Elizabeth Hospital
  • Edinburgh, United Kingdom
    • The Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have an intracranial aneurysm that the physician intends to treat with a Stryker Neurovascular device(s).

Description

Inclusion Criteria (Evolve EU and Evolve FR):

• Subject has an intracranial aneurysm that can be treated with one of the proposed devices
• Subject age is ≥ 18 years
• Subject or subject's legally authorized representative (LAR) has signed written informed consent
• Subject is willing to comply with scheduled visits and examinations per institutional standard of care

Exclusion Criteria for (Evolve EU and Evolve FR):

• Subject is pregnant or plans to become pregnant her study participation*.
• Subject is currently enrolled in or plans to be enrolled in a concurrent drug or device study.
• Subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow-up, e.g.).
• Subject has a non-target aneurysm treated within 30 days prior to study enrollment.
• Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study.
• Subject target aneurysm is a ruptured intracranial aneurysm (unless ruptured at least 21 days prior the day of the index procedure)
• Subject has a target aneurysm other than saccular or fusiform intracranial aneurysms; e.g.: vertebrobasilar dolichoectasia (VBD)
• The parent vessel size does not fall within the indicated range defined by IFU
• Antiplatelet and/or anticoagulation therapy (e.g., aspirin and clopidogrel) is contraindicated for the subject
• Subject has not received dual anti-platelet agents prior to the procedure or equivalent in accordance with standard medical practice
• Subject has an active bacterial or viral infection
• The angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as:
• Severe intracranial vessel tortuosity or stenosis; and/or
• Intracranial vasospasm not responsive to medical therapy

Additional Key Exclusion Criteria (Evolve EU only):

• Subject has a non-target aneurysm treated within 30 days prior to study enrollment
• Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study
• Subject has a modified Rankin Score (mRS) ≥3 at pre-procedure examination
• Subject has undergone previous stent assisted coiling or flow diverter treatment of a parent artery aneurysm near the location of the target aneurysm

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Evolve EU; Selected hospitals for participation	Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent; The flow diverter brings about a reduction of blood flow to the aneurysm, which progresses over time into forming a stable thrombus within the aneurysm, as well as eventual aneurysm scarring and retraction. The flow diverter also acts as a scaffold for tissue growth across the neck of the aneurysm, which blocks the aneurysm from the artery blood flow.
Evolve FR; All hospitals in France using the device	Device: Endovascular treatment of intracranial aneurysms using a flow-diverting stent; The flow diverter brings about a reduction of blood flow to the aneurysm, which progresses over time into forming a stable thrombus within the aneurysm, as well as eventual aneurysm scarring and retraction. The flow diverter also acts as a scaffold for tissue growth across the neck of the aneurysm, which blocks the aneurysm from the artery blood flow.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Zsolt Kulcsár, PhD., MD, Universitätsspital Zürich, Klinik für Neuroradiologie; Principal Investigator: Jean-Christophe Gentric, PhD., MD, CHU Cavale Blanche Brest

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CDM10001731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After completion of the 12-month primary endpoint report, and under the guidance of a physician lead publication committee, a multi-center abstract reporting the results will be prepared and may be presented at a major meeting(s). A multi-center publication may also be prepared for publication in a peer reviewed scientific journal.
• IPD Sharing Time Frame: After completion of the 12-month primary endpoint report
• IPD Sharing Access Criteria: A final report will be completed describing the results of all pre-specified outcomes, including negative results. The Sponsor will ensure investigators and regulatory authorities will receive the information contained in the final report.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No