Trenza Embolization Device for Intrasaccular Aneurysm Treatment

Stryker

Status: Active, not recruiting

Conditions: Aneurysm; Intracranial Aneurysm

Study type: Observational

Funder types: Industry

Identifiers

NCT04380350

CDM10001446

Details and patient eligibility

About

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.

Full description

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

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.