The trial is taking place at:
B

Baptist Health | Research Institute

Veeva-enabled site

Citadel Embolization Device Study

Stryker logo

Stryker

Status

Enrolling

Conditions

Unruptured Wide-neck Aneurysms

Treatments

Device: Citadel Embolization Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04057352
CDM10001448

Details and patient eligibility

About

The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms.

Full description

In this study, use of the Citadel Embolization Device will be limited to a population of patients with unruptured or ruptured wide-neck aneurysms who meet all study eligibility criteria. The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age is ≥18 and ≤80 years
  • 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.
  • Aneurysm morphology is saccular
  • Aneurysm size is between 6-12 mm
  • Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio <2 or neck ≥4 mm
  • If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt & Hess Score of 1 or 2.
  • Must be willing to comply with protocol required procedures and follow up
  • 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

  • Target aneurysm has been previously treated
  • Target aneurysm is in any extradural location, including the extradural cavernous segment
  • Has vessel characteristics, tortuosity or morphology or unfavorable aneurysm morphology (e.g., determined from baseline or preprocedure imaging, or which may be evidenced by excessive resistance felt during the procedure) that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
  • Has significant intracranial atherosclerotic disease or stenosis determined from baseline or pre-procedure imaging
  • If the target intracranial aneurysm is classified as ruptured, patient is neurologically unstable or has a Hunt & Hess Score of ≥ 3
  • Has a history of intracranial vasospasm not responsive to medical therapy
  • 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
  • Treatment with flow diverting stent implant is anticipated
  • A planned, staged procedure is anticipated
  • 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
  • Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage
  • Has a baseline mRS score ≥2
  • Has a known coagulopathy or is on chronic anticoagulant therapy
  • Is pregnant or intends to become pregnant during the study or is breastfeeding
  • Is concurrently involved in another study that could affect outcomes of IA treatment
  • 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
  • Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure, and any other contraindications listed in the Investigational DFU

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Citadel Embolization Device
Other group
Description:
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Treatment:
Device: Citadel Embolization Device

Trial contacts and locations

21

Loading...

Central trial contact

Stacy Phung; John Strohmeyer

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems