US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
- Conditions
- Aneurysm, Intracranial
- Registration Number
- NCT04852783
- Lead Sponsor
- Cerus Endovascular, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
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Patient is 18-75 years of age at the time of screening.
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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.
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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
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Patient may be treated with Contour without the use of additional implanted devices.
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Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
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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
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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
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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.
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Patient must be neurologically stable with Hunt & Hess Score of I, II or III.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 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. 30 days Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
- Secondary Outcome Measures
Name Time Method Key Secondary Effectiveness Endpoint 1 year The trial's secondary endpoint is the proportion of subjects with angiographic aneurysmal recurrence defined as aneurysm growth or recanalization at one (1) year after treatment.
Key Secondary Safety Endpoint 1 year Proportion of subjects with death of any non-accidental cause or any major stroke (an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the NIHSS as of day 7 post onset) within the first 30-days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 after treatment.
A major stroke is "a stroke, which increased the NIHSS by ≥ 4 at the time of assessment and which remained present after 7 days"
Trial Locations
- Locations (20)
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Baptist Health
🇺🇸Jacksonville, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Advocate Aurora Health
🇺🇸Park Ridge, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
UMASS Medical Center
🇺🇸Worcester, Massachusetts, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
University at Buffalo Neurosurgery
🇺🇸Buffalo, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
NC Heart and Vascular Research LLC
🇺🇸Raleigh, North Carolina, United States
The Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Alejandro Spiotta
🇺🇸Charelston, South Carolina, United States
Semmes-Murphy Clinic
🇺🇸Memphis, Tennessee, United States
Medical City Plano
🇺🇸Plano, Texas, United States
Swedish Neuroscience Institute
🇺🇸Seattle, Washington, United States