Trenza Embolization Device for Intrasaccular Aneurysm Treatment

Intracranial Aneurysm Clinical Trial

Official title:

Trenza Embolization Device for Intrasaccular Aneurysm Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04380350
• Other study ID #: CDM10001446
• Status: Recruiting
• Start date: December 17, 2020
• Est. completion date: March 30, 2027

Study information

• Verified date: November 2023
• Source: Stryker Neurovascular
• Contact: Fadila Latamene
• Phone: + 267 337 5012
• Email: fadila.latamene[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 30, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
Austria	Salzburg University Hopsital	Salzburg
Finland	Helsinski University Hospital	Helsinki
Finland	Turun yliopistollinen keskussairaala	Turku
France	Bordeaux Hopsital	Bordeaux
France	Brest Hospital	Brest
France	HCL Lyon	Lyon
France	Montpellier Hospital	Montpellier
France	APHP Bicêtre	Paris
France	Purpan Hospital	Toulouse
Germany	Klinikum Augsburg	Augsburg
Germany	Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH	Bochum
Germany	Asklepios Hospital Hamburg St. Georg	Hamburg
Germany	Universitätsklinikum Schleswig-Holstein Campus Lübeck	Lübeck
Germany	Klinikum rechts der Isar der Technischen Universität München	Munich
Germany	Klinikum Nürnberg Süd	Nürnberg
Italy	Besta hopsital	Milano
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital Universitario 12 de octubre	Madrid
Spain	Hospital Universitario Central De Asturias (HUCA)	Oviedo
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham
United Kingdom	NHS Lothian	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Safety secondary outcome measure	The secondary safety endpoint of this study is any stroke event occurring through 12 months post-procedure where a stroke event is defined as: • Rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke (i.e., intraparenchymal hemorrhage [IPH], subarachnoid hemorrhage [SAH], subdural hemorrhage [SDH], epidural hemorrhage [EDH]) accompanied with radiological evidence.	1 year (± 6 months)