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Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)

RecruitingNAAges 18 Years - 75 YearsAllCerus Endovascular, Inc.
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to collect additional data to demonstrate if the Contour Neurovascular System (CNS) is a safe and effective treatment of wide-necked, saccular, intracranial aneurysms. Participants will: Undergo treatment with the Contour Neurovascular System Complete follow-up visits at 1month, 12months, and 24 months, following their procedure Report any adverse events to their study team

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patient is 18-75 years of age at the time of screening. 2. 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 after the index procedure. 3. 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 4. Patient may be treated with Contour without the use of additional implanted devices. 5. Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule. 6. 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 7. Patient meets the criteria outlined in the "Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms" as published by the AHA/ASA\^6 FOR PATIENTS WITH RUPTURED ANEURYSM 8. 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.\^6 9. Patient must be neurologically stable with Hunt \& Hess Score of I, II or III. (\^6: 6 https://www.ahajournals.org/doi/full/10.1161/STR.0000000000000070) Exclusion Criteria: 1. Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee 2. Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device 3. Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device. 4. Contraindication to anticoagulants or anti-platelet medications 5. Stenosis of the target IA's parent vessel is \>50% 6. Anticoagulation medications (e.g., warfarin) that cannot be discontinued 7. Acute / chronic renal failure (unless on dialysis) or creatinine \> 2.00 mg/dl or \> 182 μmol/L 8. Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device. 9. Clinical, angiographic or computed tomography (CT) evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation. 10. 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. 11. Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder). 12. Modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable). 13. Subarachnoid hemorrhage (SAH) from a non-index aneurysm or any other intracranial hemorrhage within 90 days. 14. 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. 15. Pregnant, breastfeeding or planning pregnancy in the next 2 years 16. Subject is enrolled in another device or drug study in which participation could confound study results. 17. Life expectancy of less than 2 years due to an illness or condition other than the index intracranial aneurysm.
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What it tests

  • Contour Neurovascular System Treatment Attempt
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Where

9 sites
Advocate Aurora Health
Park Ridge, United States
University of Kansas Medical Center
Kansas City, United States
University at Buffalo Neurosurgery
Buffalo, United States
Stony Brook University
Stony Brook, United States
NC Heart and Vascular Research LLC
Raleigh, United States
University of Pennsylvania
Philadelphia, United States
Thomas Jefferson University
Philadelphia, United States
Medical University of South Carolina
Charleston, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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