US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair (NECC)

  • STATUS
    Recruiting
  • End date
    Sep 25, 2027
  • participants needed
    220
  • sponsor
    Cerus Endovascular, Ltd
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Updated on 25 March 2022
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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.

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.

Details
Condition Aneurysm, Intracranial
Treatment Contour Neurovascular System
Clinical Study IdentifierNCT04852783
SponsorCerus Endovascular, Ltd
Last Modified on25 March 2022

Eligibility

 Yes No Not Sure

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
FOR PATIENTS WITH UNRUPTURED ANEURYSM
Patient meets the criteria outlined in the "Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms" as published by the AHA/ASA FOR PATIENTS WITH RUPTURED ANEURYSM
Patient meets the criteria outlined in the "Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association" as published by the AHA/ASA
Patient must be neurologically stable with Hunt & Hess Score of I, II or III

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
Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder)
modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable)
SAH from a non-index aneurysm or any other intracranial hemorrhage within 90 days
Physical, neurologic or psychiatric conditions which precluded his/her ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
Pregnant, breastfeeding or planning pregnancy in the next 2 years
Subject is enrolled in another device or drug study in which participation could confound study results
Life expectancy of less than 2 years due to an illness or condition other than the index intracranial aneurysm
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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