Clinical trial NCT04380350: Trenza Embolization Device for Intrasaccular Aneurysm Treatment
Official title: Trenza Embolization Device for Intrasaccular Aneurysm Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aneurysm
Intracranial Aneurysm
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2020-05-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with Trenza device

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.

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.

Primary outcomes:
measure: Safety primary outcome measure
timeFrame: 1 year (± 6 months)
measure: Effectiveness primary outcome measure
timeFrame: 1 year (± 6 months)
Secondary outcomes:
measure: Safety secondary outcome measure
timeFrame: 1 year (± 6 months)
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Salzburg University Hopsital
city: Helsinki
country: Finland
facility: Helsinski University Hospital
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: Bordeaux
country: France
facility: Bordeaux Hopsital
city: Brest
country: France
facility: Brest Hospital
city: Lyon
country: France
facility: HCL Lyon
city: Montpellier
country: France
facility: Montpellier Hospital
city: Paris
country: France
facility: APHP Bicêtre
city: Toulouse
country: France
facility: Purpan Hospital
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
city: Hamburg
country: Germany
facility: Asklepios Hospital Hamburg St. Georg
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: Milano
country: Italy
facility: Besta hopsital
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de octubre
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: Hospital Purpan, Toulouse, France
name: Christophe Cognard, Pr
role: PRINCIPAL_INVESTIGATOR
References: