Trenza Embolization Device for Intrasaccular Aneurysm Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Aneurysm; Intracranial Aneurysm

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Fadila Latamene; Phone Number: + 267 337 5012; Email: fadila.latamene@stryker.com
• Study Contact Backup: Name: John Strohmeyer; Phone Number: + 267 337 5012; Email: john.strohmeyer@stryker.com

Study Locations

• Austria
  • Salzburg, Austria
    • Recruiting
    • Salzburg University Hopsital
    • Principal Investigator: Monika Killer-Oberpfalzer, Pr
• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinski University Hospital
    • Principal Investigator: Jussi Numminen, Dr
  • Turku, Finland
    • Recruiting
    • Turun yliopistollinen keskussairaala
    • Principal Investigator: Riitta Rautio, Pr
• France
  • Bordeaux, France
    • Recruiting
    • Bordeaux Hopsital
    • Principal Investigator: Xavier Barreau, Dr
  • Brest, France
    • Recruiting
    • Brest Hospital
    • Principal Investigator: Jean Christophe Gentric, Pr
  • Lyon, France
    • Recruiting
    • HCL LYON
    • Principal Investigator: Omer Eker, Pr
  • Montpellier, France
    • Recruiting
    • Montpellier Hospital
    • Principal Investigator: Vincent Costalat, Pr
  • Paris, France
    • Recruiting
    • APHP Bicêtre
    • Principal Investigator: Laurent Spelle, Pr
  • Toulouse, France
    • Recruiting
    • Purpan Hospital
    • Principal Investigator: Christophe Cognard, Pr
• Germany
  • Augsburg, Germany
    • Withdrawn
    • Klinikum Augsburg
  • Bochum, Germany
    • Recruiting
    • Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
    • Principal Investigator: Sebastian Fischer, Dr
  • Hamburg, Germany
    • Recruiting
    • Asklepios Hospital Hamburg St. Georg
    • Principal Investigator: Jan Buhk, Dr
  • Lübeck, Germany
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Principal Investigator: Peter Schramm, Pr
  • Munich, Germany
    • Withdrawn
    • Klinikum Rechts Der Isar Der Technischen Universität München
  • Nürnberg, Germany
    • Active, not recruiting
    • Klinikum Nürnberg Süd
• Italy
  • Milano, Italy
    • Recruiting
    • Besta hopsital
    • Principal Investigator: Elisa Ciceri, Dr
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic i Provincial de Barcelona
    • Principal Investigator: Jordi Blasco, Dr
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Principal Investigator: Federico Ballenilla, Dr
  • Oviedo, Spain
    • Withdrawn
    • Hospital Universitario Central de Asturias (HUCA)
• United Kingdom
  • Birmingham, United Kingdom
    • Recruiting
    • Queen Elizabeth Hospital Birmingham
    • Principal Investigator: Saleh Lamin, Dr
  • Edinburgh, United Kingdom
    • Recruiting
    • NHS Lothian
    • Principal Investigator: Jonny Downer, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients treated with Trenza device

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Christophe Cognard, Pr, Hospital Purpan, Toulouse, France

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CDM10001446

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No