POST-MARKET SURVEILLANCE STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE WEB® DEVICE
Post-Approval Study – Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
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Clinical Trial Information
Trial Contact: Carlo, Charlene S; Monserrate, Francheska; Flores-Vega, Mariangelis; Melendez, Thomas L
Trial Phone: 321.841.1324 ; 321-841-4717 ; 321-841-717 ; 321.841.6813
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IRB No: W22.173.08
Protocol Abbrev: WEB_PAS
Principal Investigator: Jay Ashok Vachhani, MD
Phase: Device: Significant Risk
Age Group: Adult
Secondary Protocol No: CL11010-001
Treatment: WEB Device
Therapies Involved: Surgery
ClinicalTrials.gov ID: NCT04839705
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Objective
Post-market study to evaluate the long-term safety and effectiveness of the WEB Device within currently approved indications for use.
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Key Eligibility
Adult subjects with intracranial wide-neck aneurysms located at arterial bifurcations.
