Trenza Embolization Device for Intrasaccular Aneurysm Treatment

Launched by STRYKER NEUROVASCULAR · May 5, 2020

Keywords

ClinConnect Summary

The clinical trial titled "Trenza Embolization Device for Intrasaccular Aneurysm Treatment" is looking at the safety and effectiveness of a new device called the Trenza for treating certain types of brain aneurysms. An aneurysm is a weak spot in a blood vessel in the brain that can bulge out and potentially rupture, causing serious health issues. This study is open to adults aged 18 to 80 who have a specific kind of aneurysm that is either unruptured or has recently ruptured but the patient is stable. To qualify, participants must have a saccular aneurysm between 6 and 12 mm in size with certain characteristics, and they must be willing to follow the study's guidelines.

If you or someone you know is eligible to participate, the trial will involve some medical procedures to assess how well the Trenza device works. Participants will be closely monitored throughout the study, and they will need to give written consent to take part. It's important to note that there are specific criteria that could exclude someone from joining, such as having had previous treatments for the aneurysm or certain medical conditions. Overall, this trial aims to gather important information that could help improve treatment options for patients with intracranial aneurysms.

Gender

ALL

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.