Trenza Embolization Device for Intrasaccular Aneurysm Treatment

NCT ID: NCT04380350

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2027-03-30

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.

Detailed Description

Prospective, multi-center, single-arm, post-market follow-up study conducted in Europe for the treatment of patients with saccular intracranial aneurysms.

Conditions

Aneurysm; Intracranial Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Age is ≥18 and ≤80 years

2. 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).

3. Aneurysm morphology is saccular

4. Aneurysm size is between 6-12 mm

5. Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio <2 or neck ≥4 mm

6. If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt & Hess Score of 1 or 2.

7. Must be willing to comply with protocol required procedures and follow up

8. Must be willing to sign and date an Ethics Committee approved written informed consent prior to initiation of any screening or study procedures

9. 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

Exclusion Criteria

1. Target aneurysm has been previously treated.

2. 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.

3. 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.

4. Treatment with flow diverting stent implant is anticipated.

5. A planned, staged procedure is anticipated.

6. 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.

7. Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage.

8. Has a baseline mRS score ≥2 at time or presentation or prior to rupture (as applicable)

9. Has a known coagulopathy or is on chronic anticoagulant therapy.

10. Is pregnant or intends to become pregnant during the study or is breastfeeding.

11. Is concurrently involved in another study that could affect outcomes of IA treatment.

12. 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.

13. Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure.

14. Patient presents a Hunt and Hess grade III or more for a ruptured aneurysm.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Neurovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Cognard, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospital Purpan, Toulouse, France

Locations

Salzburg University Hopsital

Salzburg, , Austria

Helsinski University Hospital

Helsinki, , Finland

Turun yliopistollinen keskussairaala

Turku, , Finland

Bordeaux Hopsital

Bordeaux, , France

Brest Hospital

Brest, , France

HCL Lyon

Lyon, , France

Montpellier Hospital

Montpellier, , France

APHP Bicêtre

Paris, , France

Purpan Hospital

Toulouse, , France

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

Bochum, , Germany

Asklepios Hospital Hamburg St. Georg

Hamburg, , Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, , Germany

Besta hopsital

Milan, , Italy

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Hospital Universitario 12 de octubre

Madrid, , Spain

Queen Elizabeth Hospital Birmingham

Birmingham, , United Kingdom

NHS Lothian

Edinburgh, , United Kingdom

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Countries

Austria; Finland; France; Germany; Italy; Spain; United Kingdom

Other Identifiers

CDM10001446

Identifier Type: -

Identifier Source: org_study_id