US IDE Study of the Contour NEurovasCular Systemâ„¢ for IntraCranial Aneurysm Repair (NCT04852783) | Clinical Trial Compass
Active — Not RecruitingPhase 4
US IDE Study of the Contour NEurovasCular Systemâ„¢ for IntraCranial Aneurysm Repair
United States250 participantsStarted 2021-08-06
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
✓. 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.
✓. 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.
Exclusion criteria
✕. Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
✕
What they're measuring
1
Primary Safety Endpoint: Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
Timeframe: 30 days
2
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.