Status:
ACTIVE_NOT_RECRUITING
US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
Lead Sponsor:
Cerus Endovascular, Inc.
Conditions:
Aneurysm, Intracranial
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 submissio...
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 submissio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04852783
Start Date
August 6 2021
End Date
December 1 2029
Last Update
December 20 2024
Active Locations (20)
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1
Swedish Medical Center
Englewood, Colorado, United States, 80113
2
Baptist Health
Jacksonville, Florida, United States, 32207
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Advocate Aurora Health
Park Ridge, Illinois, United States, 60068