US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Aneurysm, Intracranial
- Sponsor
- Cerus Endovascular, Inc.
- Enrollment
- 250
- Locations
- 20
- Primary Endpoint
- Primary Effectiveness Endpoint: Complete occlusion of the aneurysm with Contour without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment as assessed by the angiographic core laboratory.
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device.
Detailed Description
The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device. This trial is a prospective, multicenter single-arm study. Up to 220 subjects will be enrolled at up to 20 participating investigational sites.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is 18-75 years of age at the time of screening.
- •Patient has a single ruptured or unruptured IA requiring treatment. If the patient has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure.
- •The target IA must have the following characteristics:
- •Saccular morphology
- •Located at a bifurcation in the anterior or posterior circulation
- •Aneurysm neck diameter between 2 and 10 mm and aneurysm equatorial diameter between 2 and 10.5 mm
- •Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio \< 2
- •Patient may be treated with Contour without the use of additional implanted devices.
- •Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
- •Patient or legally authorized representative has signed and dated an institutional review board (IRB)/Ethics Committee (EC)-approved written informed consent prior to initiation of any study procedures.
Exclusion Criteria
- •Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
- •Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
- •Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.
- •Contraindication to anticoagulants or anti-platelet medications
- •Stenosis of the target IA's parent vessel is \>50%
- •Anticoagulation medications (e.g., warfarin) that cannot be discontinued
- •Acute / chronic renal failure (unless on dialysis) and/or creatinine \> 2.00 mg/dl or \> 182 μmol/L
- •Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
- •Clinical, angiographic or CT evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
- •Conditions placing them at high risk for ischemic stroke or had exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60-days.
Outcomes
Primary Outcomes
Primary Effectiveness Endpoint: Complete occlusion of the aneurysm with Contour without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment as assessed by the angiographic core laboratory.
Time Frame: 1 year
Complete occlusion of the aneurysm with Contour as defined by complete aneurysm occlusion (Raymond Roy Scale , of 1) without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis (\> 50% stenosis) at one (1) year after treatment as assessed by the angiographic core laboratory.
Primary Safety Endpoint: Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
Time Frame: 30 days
Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
Secondary Outcomes
- Key Secondary Effectiveness Endpoint(1 year)
- Key Secondary Safety Endpoint(1 year)