Trenza Embolization Device for Intrasaccular Aneurysm Treatment

NCT04380350 | Active Not Recruiting

• 1 other identifier: CDM10001446
• Study Type: observational
• Target: 150
• Locations: 7 countries
• Sites: 18

Brief Summary

The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.

Conditions

Aneurysm; Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• Safety primary outcome measure

  The primary safety endpoint of this study is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery, occurring within 12 months post-procedure as adjudicated by an independent Clinical Events Committee (CEC) * With major ipsilateral stroke defined as a stroke associated with an increase in NIHSS score ≥ 4 points persisting ≥ 24 hours, and; * With disabling stroke defined as a stroke that results in a modified Rankin Scale (mRS) score ≥ 3 assessed at a minimum of 90 days post-stroke event.

  1 year (± 6 months)

• Effectiveness primary outcome measure

  The primary effectiveness endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (\>50% stenosis). The determination of adequate aneurysm occlusion using Raymond-Roy classification will be made if either of the following criteria are met: * 100% occlusion (Raymond Class I) demonstrated by angiographic measurement at 12 months (+6/-3 months) post-procedure, or * Stable Raymond Class II demonstrated on 2 serial angiographic measurements obtained a minimum of 6 months (± 1 month) apart

  1 year (± 6 months)

Secondary Outcomes (1)

• Safety secondary outcome measure

  1 year (± 6 months)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated with Trenza device

You may qualify if:

• Age is ≥18 and ≤80 years
• Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment (Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days).
• Aneurysm morphology is saccular
• Aneurysm size is between 6-12 mm
• Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio \<2 or neck ≥4 mm
• If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt \& Hess Score of 1 or 2.
• Must be willing to comply with protocol required procedures and follow up
• Must be willing to sign and date an Ethics Committee approved written informed consent prior to initiation of any screening or study procedures
• Subject or LAR must be willing to sign and date an IRB approved written informed consent prior to initiation of any screening or study procedures

You may not qualify if:

• Target aneurysm has been previously treated.
• Has significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm refractory to medication, unfavorable aneurysm morphology or vessel anatomy, or some other condition(s) that, prevents or interferes with access to the target aneurysm.
• Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm.
• Treatment with flow diverting stent implant is anticipated.
• A planned, staged procedure is anticipated.
• Has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), intracranial hematoma(s), any other intracranial vascular malformation, or any previous major intracranial surgery.
• Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage.
• Has a baseline mRS score ≥2 at time or presentation or prior to rupture (as applicable)
• Has a known coagulopathy or is on chronic anticoagulant therapy.
• Is pregnant or intends to become pregnant during the study or is breastfeeding.
• Is concurrently involved in another study that could affect outcomes of IA treatment.
• Has evidence of active cancer, terminal illness, high risk of embolic stroke, atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years.
• Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure.
• Patient presents a Hunt and Hess grade III or more for a ruptured aneurysm.

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (18)

Salzburg University Hopsital

Salzburg, Austria

Location

Helsinski University Hospital

Helsinki, Finland

Location

Turun yliopistollinen keskussairaala

Turku, Finland

Location

Bordeaux Hopsital

Bordeaux, France

Location

Brest Hospital

Brest, France

Location

HCL Lyon

Lyon, France

Location

Montpellier Hospital

Montpellier, France

Location

APHP Bicêtre

Paris, France

Location

Purpan Hospital

Toulouse, France

Location

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

Bochum, Germany

Location

Asklepios Hospital Hamburg St. Georg

Hamburg, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany

Location

Besta hopsital

Milan, Italy

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital Universitario 12 de octubre

Madrid, Spain

Location

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Location

NHS Lothian

Edinburgh, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Aneurysm; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christophe Cognard, Pr

  Hospital Purpan, Toulouse, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: December 17, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-02

Locations

FI (2); FR (6); AU (1); DE (3); GB (3); ES (2); IT (1)